Omeros Corporation Announces Expansion of Exclusive License to PDE7 Inhibitors from Daiichi Sankyo, Inc.

SEATTLE, Feb. 22, 2011 /PRNewswire/ -- Omeros Corporation (Nasdaq:OMER - News) today announced that its exclusive license to phosphodiesterase 7 (PDE7) inhibitors from Daiichi Sankyo Co., Ltd. has been amended to include addiction and compulsive disorders in the field of use. Omeros' PDE7 program was founded on the Company's discovery of a previously unknown link between PDE7 and any movement disorder, such as Parkinson's disease. Omeros believes that it also is the first to link PDE7 to any addiction or compulsive behavior, and is now advancing PDE7 inhibitors for the treatment of these as well as movement disorders. Omeros is collaborating on this program with both the National Institute on Drug Abuse (NIDA) and The Michael J. Fox Foundation.

"We are pleased to announce our agreement with Daiichi Sankyo and the additional therapeutic focus of our PDE7 program," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "From the advanced Daiichi compounds we have already selected a clinical candidate, and we expect that addiction will provide us with a faster and less expensive development pathway for our PDE7 program. We are collaborating with NIDA on additional studies that will evaluate our compounds in addiction, and we look forward to working with NIDA to advance this program through the clinic."

PDE7 appears to modulate the dopaminergic system, which plays a significant role in regulating both movement and addiction. Omeros believes that PDE7 inhibitors could be effective therapeutics for the treatment of movement disorders as well as addiction and compulsive disorders. Omeros has shown in animal models of cocaine addiction that PDE7 inhibitors reduce cocaine self-administration, inhibit relapse induced by cues and stress, and facilitate drug abstinence in previously addicted animals. Importantly, no effect on normal feeding was observed in the cocaine studies, suggesting that PDE7 inhibitors selectively reduce addiction-related behaviors. In a similarly well-established animal model of binge eating, Omeros' PDE7 inhibitors demonstrated equally robust efficacy, again showing no effect on normal feeding behavior.

Omeros' PDE7 Program Expands its Addiction Franchise

As previously announced, Omeros is evaluating peroxisome proliferator-activated receptor gamma (PPAR gamma) agonists for the treatment of addiction in two Phase 2 clinical studies being conducted by researchers at the New York State Psychiatric Institute. NIDA is funding substantially all costs of these studies, which are evaluating the effects of PPAR gamma agonists on oxycontin and heroin use. Pilot human and preclinical data suggest that PPAR gamma agonists may be most effective in the treatment of addiction to opioids, alcohol and nicotine, and that they are less effective for treating addiction to psychostimulants such as cocaine and methamphetamine. In contrast, preclinical data suggest that PDE7 inhibitors may be effective in the treatment of addiction to cocaine and methamphetamine, nicotine and compulsive behaviors. Together, the PPAR gamma and PDE7 programs provide Omeros with a potentially broad franchise of drug treatments for addiction and compulsive disorders.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has six ongoing clinical development programs, including four from its PharmacoSurgery™ platform, the most advanced of which is in a Phase 3 clinical program, and two from its addiction franchise. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, bleeding and central nervous system disorders.

Forward-looking Statements

This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release and include Omeros' belief that PDE7 inhibitors could be effective therapeutics for the treatment of movement disorders as well as addiction and compulsive disorders, that addiction could provide a faster and less expensive development pathway for the PDE7 program, that NIDA will work with Omeros to advance the PDE7 program through the clinic, that the PPAR gamma and PDE7 programs provide Omeros with a potentially broad franchise of drug treatments for addiction and compulsive disorders, and that Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2010. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

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Medivir AB Announces Positive Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-Naive Patients Chronically Infected With Genotype-1 Hepatitis C Virus

HUDDINGE, Sweden, February 22, 2011 /PRNewswire-FirstCall/ -- Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.

- TMC435 was safe and well tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care (SoC). - In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24 - Potent and consistent antiviral efficacy was demonstrated with SVR24 rates of up to 84%

"We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen" stated Bertil Samuelsson, CSO of Medivir. "The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011."

The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naive patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.

Study design

In the PILLAR study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain predefined response-guided criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the above response-guided criteria continued with SoC until week 48 as did the placebo group.

Evaluation criteria

A protocol-defined interim analysis was performed when all patients completed their Week 48 visit or discontinued treatment earlier. Final SVR4 and SVR24 data were available for 98% (303/309; n/N) and 93% (288/309; n/N) of TMC435 treated patients, respectively. SVR24 is determined 24 weeks after the planned end of treatment (EoT) and was therefore not yet available for the patients in the placebo group and for some of those in the TMC435 group who received 48 weeks of treatment. SVR4, which is determined 4 weeks after the planned EoT, was available for 77% (59/77; n/M) of the patients in the placebo group.

Results - Efficacy

Potent and sustained antiviral efficacy was demonstrated in the SVR4 and SVR24 rates with no major differences between TMC435 doses or length of triple therapy. At week 4 after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week 4 after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.

The results are derived from an intent-to-treat (ITT) analysis of the patient population who took at least one dose of the study medication and who reached the criteria for stopping all treatment at 24 weeks (83%).

Sustained Virological Response 4 and 24 Weeks after Planned End of Treatment (EoT);

TMC435 TMC435 TMC435 TMC435 Placebo 12PR24 24PR24 12PR24 24PR24 75mg q.d. 75mg q.d. 150mg q.d. 150mg q.d. % (n/N) N=78 N=75 N=77 N=79 N=77 SVR4 87.2 (68/78) 86.5 (64/74) 84.9 (62/73) 88.5 (69/78) 71.2 (42/59) SVR24 83.6 (61/73) 76.1 (51/67) 83.1 (59/71) 84.4 (65/77) N/A

* < 25 log10 IU/mL undetectable q.d.: once daily, PR: pegIFNalpha-2A and ribavirin,

SVR4 and SVR24: patients with undetectable HCV RNA 4 and 24 weeks after planned EoT, respectively. N/A: Patients in the control arm continue SoC until Week 48 and SVR24 data was not available

Results - Safety and Tolerability

TMC435 was generally safe and well tolerated and overall incidence of adverse events (AEs) was similar across treatment groups. AEs leading to discontinuation of TMC435 or placebo treatment were reported in 7.8% of the placebo subjects and in 7.1% of the TMC435 treated subjects. In the safety analyses, special attention was given to the following AEs of interest: hepatobiliary AEs, pruritus, rash, anemia, and cardiac events. For each category of AEs of interest; the incidence was similar between TMC435 and placebo.

In laboratory parameters, there were no clinically relevant differences between any TMC435 groups and placebo except for mild on treatment reversible bilirubin elevations (total, direct and indirect) in the 150 mg TMC435 arm, which were normalized after TMC435 dosing was completed. There were no meaningful differences between treatment groups for any of the other laboratory parameters. Significant and rapid decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups.

Conference Call For Analysts and Investors:

There will be a conference call today, February 22 2011, for investors and sell-side analysts at 09:00 (EDT) / 14:00 (GMT) / 15:00 (CET) with the management team of Medivir to discuss this announcement. To dial-in to the conference call please use the following numbers:

Participant Telephone Numbers: +1-718-354-1385 USA +46(0)8-5352-6408 Sweden +44(0)20-7806-1951 UK Confirmation Code: 6641746

Alternatively, please contact Lindsey Neville at M:Communications on Tel: +44(0)207-920-2333, Email: Neville@mcomgroup.com.

Notes to Editors

About TMC435 in other clinical studies

TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.

The clinical phase 3 program started recently including

- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive patients - TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive patients - TMC435-C3007 or PROMISE includes approximately 375 who have relapsed after prior interferon-based treatment

In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.

A phase 3 program for TMC435 has also recently been launched in Japan.

For additional information for these studies, please see http://www.clinicaltrials.gov

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(R). Medivir's key pipeline asset, TMC435, a protease inhibitor, recently entered global phase 3 development for the treatment of hepatitis C and is partnered with Tibotec Pharmaceuticals.

Xerese(TM)/Xerclear(R) is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GlaxoSmithKline to be sold OTC in Europe and Russia and with Meda AB in North America. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.

For more information on Medivir, please see the company website: http://www.medivir.com

For additional information, please contact

Medivir (http://www.medivir.se)

Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 M:Communications

Europe: Mary-Jane Elliott/ Amber Bielecka /Nick Francis Medivir@mcomgroup.com +44(0)20-7920-2330

USA: Roland Tomforde +1-212-232-2356

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Arena Pharmaceuticals, Inc. Announces Upcoming Departure of Chief Financial Officer

SAN DIEGO, Feb. 10, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq:ARNA - News) announced today the resignation of Robert E. Hoffman, Vice President, Finance and Chief Financial Officer. Mr. Hoffman, who has accepted a new position in the healthcare industry, will remain in his current role at Arena until the reporting of the company's year-end results and the filing of the Form 10-K for the year ended December 31, 2010.

"We thank Robert for his many years of valuable service and contribution to Arena and wish him the best in his future endeavors," said Jack Lief, Arena's President and Chief Executive Officer. "Robert has built a strong finance team at Arena, and we are focused on ensuring a smooth transition when he departs next month."

In the interim, Jennifer K. Bielasz, Senior Director of Accounting and Controller, and Carolyn M. Felzer, Senior Director of Finance, will continue to play key leadership roles in Arena's finance department. Ms. Bielasz joined Arena in 2001 and is responsible for managing all accounting, stock administration and tax compliance activities. Prior to joining Arena, she served as the controller of both public and private companies, including as Vice President and Controller of Guild Mortgage Company. Ms. Felzer joined Arena in 2006 and is responsible for public reporting, Sarbanes-Oxley compliance, 401(k) and other administrative functions. Prior to joining Arena, she served as Senior Director of Finance and Administration at Salmedix, Inc., until its acquisition by Cephalon, Inc., and as Corporate Secretary and Vice President and Controller at Corvas International, Inc., until its acquisition by Dendreon Corporation. Ms. Bielasz and Ms. Felzer both began their careers at KPMG LLP.

About Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States following FDA approval of the New Drug Application (NDA) for lorcaserin.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Mr. Hoffman's continuing role at Arena, the transition related to his departure and the continuing roles of other members of the finance department; the potential therapeutic indication and use, FDA approval and commercialization of lorcaserin; the Eisai collaboration and potential activities thereunder; and Arena's focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the risk that regulatory authorities may not find data and other information related to Arena's clinical trials and other studies meet safety or efficacy requirements or are otherwise sufficient for regulatory approval; the timing of regulatory review and approval is uncertain; Arena's response to the complete response letter for the lorcaserin NDA may not be submitted when anticipated or the information provided in such response may not satisfy the FDA; the FDA may request other information prior to or after Arena resubmits the lorcaserin NDA or approval of the lorcaserin NDA; unexpected or unfavorable new data; risks related to commercializing new products; Arena's ability to obtain and defend its patents; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner Arena or others expect or at all; Arena's ability to obtain adequate funds; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc.

Media Contact: Russo Partners

Jack Lief David Schull, President President and CEO david.schull@russopartnersllc.com 858.717.2310

Cindy McGee Manager, IR and Corporate Communications Anthony J. Russo, Ph.D., CEO 858.453.7200, ext. 1479 tony.russo@russopartnersllc.com 212.845.4251

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Orexigen Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer

SAN DIEGO, Feb. 17, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq:OREX - News) announced today the upcoming resignation of Graham Cooper, senior vice president, Finance, CFO and treasurer. Mr. Cooper, who has been with Orexigen for over four years, has decided to leave the Company for personal reasons. He has been commuting from the San Francisco Bay Area since accepting the CFO role in 2006. Mr. Cooper will remain in his current role at Orexigen until the reporting of the Company's year-end results and the filing of its Annual Report on Form 10-K with the SEC for the year ended December 31, 2010.

The Company intends to name Jay Hagan, senior vice president, Corporate Development and Strategy, as acting-CFO and transition the financial operation responsibilities to him. Jay joined the company in May 2009 after 10 years at Amgen. He was instrumental in helping Orexigen secure the partnership with Takeda Pharmaceuticals North America for Contrave® (naltrexone Sustained Release (SR)/bupropion SR). Since joining the Company to lead Corporate Development in 2009, Mr. Hagan has taken on increased responsibility, leading the Corporate Communications and Technical Operations functions at Orexigen.

"We are very grateful to Graham for his dedication and many contributions to Orexigen, and we wish him great success in the future," said Michael Narachi, president and CEO of Orexigen. "Graham has built a strong finance team at Orexigen, which will enable a smooth transition."

Steve Moglia, senior director of Financial Reporting and controller, and Judy Fox, assistant controller will continue to play key leadership roles in Orexigen's Finance department. Mr. Moglia joined Orexigen in 2008 and is responsible for managing all financial reporting, Sarbanes-Oxley compliance, stock administration and tax compliance activities. Prior to joining Orexigen, Mr. Moglia served as the director of SEC Reporting and Compliance at Biosite, Inc. Mr. Moglia is a certified public accountant (inactive) in the state of California. Ms. Fox joined Orexigen in 2007 and is responsible for accounting, financial management, 401(k) and other accounting related administrative functions. Prior to joining Orexigen, she served as assistant controller at Diversa Corporation. Ms. Fox received her MBA from California State University, San Marcos.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product, Contrave®, has completed Phase 3 clinical trials and has received a Complete Response Letter from the FDA for its New Drug Application. The Company is in the process of determining the next steps for Contrave. The Company's second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at www.orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding Mr. Cooper's departure from the Company, Mr. Cooper's role with the Company until his departure, the transition of the financial responsibilities to Mr. Hagan, the continuing roles of other members of the finance department and the next steps for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the uncertainty of the FDA approval process and other regulatory requirements; Orexigen's ability to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to attract and retain key personnel; Orexigen's ability to maintain sufficient capital; and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q, which we intend to file with the Securities Exchange Commission this week and will be available from the SEC's website (www.sec.gov) and on our website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

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Upsher-Smith Laboratories Announces the Voluntary Nationwide Recall of Jantoven(R) Warfarin Sodium Tablets, USP, 3mg, Due to Mislabeled Bottles

MAPLE GROVE, Minn., Feb. 16, 2011 /PRNewswire/ -- Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily recalling one lot (lot #284081) of Jantoven® Warfarin Sodium, USP, 3mg Tablets, an anticoagulant with an expiration date of September 2012, NDC # 0832-1214-00. The company is initiating the recall as a precautionary measure after a single bottle labeled as Jantoven® Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed. To date, the company has identified no additional mislabeled bottles.

At Upsher-Smith, patient safety is of foremost concern. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.

Consistent, continuous dosing of warfarin is necessary for optimal care for many ill patients. For this reason, patients' doses must be adjusted by regular measurements of the degree of anticoagulation to assure warfarin use is safe and effective. Either abrupt interruption of this medication, or administration of an inappropriately high dose, could present a serious health risk. Patients should check with their health care provider regarding the appropriateness of their current therapy prior to making any change.

The two Jantoven tablets can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832.

(Photo: http://photos.prnewswire.com/prnh/20110216/NY49997-a )

(Photo: http://photos.prnewswire.com/prnh/20110216/NY49997-b )

Upsher-Smith Laboratories is working cooperatively with the U.S. Food and Drug Administration to implement a nationwide recall as quickly and efficiently as possible.

The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled product. The product was packaged at the Upsher-Smith plant in Plymouth, Minnesota.

Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).

Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:

www.fda.gov/MedWatch/report.htm

Regular:

Use postage-paid, pre addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a privately held pharmaceutical company that develops, manufactures and markets prescription and over-the-counter products. Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and CNS diseases. Upsher-Smith is headquartered in Maple Grove, Minn. For more information, visit www.upsher-smith.com.

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Inspire Pharmaceuticals, Inc. Announces Corporate Restructuring; Cuts 27 Pct of Jobs and Drops Lung Drug

RALEIGH, N.C.--(BUSINESS WIRE)-- Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH - News) announced today a strategic corporate restructuring designed to result in the Company focusing activities on its eye care business, allowing it to fully leverage existing commercial capabilities, pipeline assets and related corporate development and licensing opportunities.

Adrian Adams, President and CEO of Inspire, stated, “We conducted a strategic evaluation of our operations following the recent announcement of the disappointing results with our cystic fibrosis (CF) program and believe the prudent strategy for Inspire is to leverage our eye care business and discontinue our pulmonary therapeutic focus. Therefore, we are implementing a substantial corporate restructuring that we anticipate will enable us to drive toward profitability and positive cash flow by significantly reducing our cost base and cash burn. Our eye care business continues to generate an attractive revenue stream from growth in our anchor product, AZASITE® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, and royalties from other ophthalmic products.”

“Our assessment of the full data set from the TIGER-2 Phase 3 trial of denufosol tetrasodium for the treatment of CF, the open-label DEFY trial data and our current corporate resources supports our decision to discontinue Inspire’s development of denufosol. We want to express our sincere gratitude to the CF community including the many patients, families and care providers who supported denufosol research through their participation in our clinical trials. We also want to recognize and thank the employees affected by the corporate restructuring for their many contributions to the Company,” Adams concluded.

The corporate restructuring includes a workforce reduction of approximately 65 positions, or 27% of total headcount, which represents 45% of non-sales force headcount, primarily affecting functions in Research & Development (R&D), Manufacturing & Technical Operations and General & Administrative. There are minimal changes to the commercial infrastructure and no reductions to Inspire’s specialty eye care sales force. This strategic restructuring is estimated to result in a more than $40 million reduction in 2011 non-cost of sales operating expenses, excluding restructuring charges, as compared to 2010. This amount is estimated to include approximately $10 million of compensation expense savings and up to $30 million in reduced R&D spending. The Company expects to record a restructuring charge of $10-$13 million in the first quarter of 2011, which will include severance costs, termination of ongoing denufosol contracts and activities and the write-off of impaired assets and idle facility charges.

As mentioned in Inspire’s financial results release issued today, Inspire will host a conference call and live webcast to discuss its fourth quarter and full year 2010 financial results, 2011 financial guidance and corporate restructuring on Thursday, February 17, 2011 at 8:00 a.m. ET. To access the conference call, U.S. participants may call (877) 648-7970 and international participants may call (706) 902-0415. The conference ID number is 43734225. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until February 24, 2011. To access this replay, U.S. participants may call (800) 642-1687 and international participants may call (706) 645-9291. The conference ID number is 43734225.

About Inspire

Inspire is a specialty pharmaceutical company focused on developing and commercializing ophthalmic products. Inspire’s strategy is to create a sustainable portfolio of products by leveraging its commercial capabilities and pipeline assets and pursuing corporate development and licensing opportunities. Inspire’s specialty eye care sales force generates revenue from the promotion of AZASITE® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis and the co-promotion of ELESTAT® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis. Inspire receives royalties based on net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% for dry eye and expects to begin receiving royalties in 2011 based on net sales of DIQUAS™ Ophthalmic Solution 3% (diquafosol tetrasodium) for dry eye. For more information, visit www.inspirepharm.com.

Forward-Looking Statements

The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurances can be made with respect to: Inspire's ability to focus its activities on its eye care business and fully leverage its existing commercial capabilities, pipeline assets and related corporate development and licensing opportunities; the prudence of leveraging Inspire's eye care business and discontinuing its pulmonary therapeutic focus; that implementation of the corporate restructuring will enable Inspire to drive towards profitability and positive cash flow, or to significantly reduce its cost base or cash burn; that Inspire's eye care business will continue to generate an attractive revenue stream from growth in AZASITE and royalties from other ophthalmic products; that the corporate restructuring will result in a more than $40 million reduction in 2011 non-cost of sales operating expenses, excluding restructuring charges, as compared to 2010; that the reduction in 2011 operating expenses from the corporate restructuring will include $10 million of compensation expense savings and $30 million in reduced R&D spending; that Inspire will record a restructuring charge of $10-$13 million in the first quarter of 2011, which will include severance costs, termination of ongoing denufosol contracts and activities and the write-off of impaired assets and idle facility charges; and Inspire's ability to create a sustainable portfolio of products by leveraging its commercial capabilities and pipeline assets and pursuing corporate development and licensing opportunities. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the introduction of a generic form of epinastine, intellectual property rights, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.

Contact:

Investor Contact: Inspire Pharmaceuticals, Inc. Jenny Kobin VP, Investor Relations and Corporate Communications 919-287-1219 or Inspire Pharmaceuticals, Inc. Media Contact: Cara Amoroso Associate Director, Corporate Communications 919-287-1266

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Halozyme Therapeutics, Inc. Announces Roche Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment

Halozyme Therapeutics, Inc. (HALO) Announces Roche (RHHBY) Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera(R) (rituximab); Triggering $5 Million Milestone Payment
2/16/2011

SAN DIEGO, Feb. 16, 2011/PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the first patient received subcutaneous (SC) MabThera (rituximab), an anticancer biologic, in a Phase 3 registration trial using Enhanze( technology (rHuPH20, recombinant human hyaluronidase). This represents the second Roche cancer medicine, in addition to Herceptin® SC (trastuzumab), to enter a Phase 3 registration study as part of the Halozyme-Roche collaboration. Initiation of the clinical trial has triggered a milestone payment of $5 million to Halozyme. MabThera is approved to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL) using different induction and maintenance treatments that are currently given intravenously (IV).

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"The start of this Phase 3 subcutaneous MabThera trial in patients with follicular NHL signifies another major achievement for the Halozyme-Roche partnership, and represents the second Roche target to begin a pivotal trial. I congratulate the team on this important accomplishment," said Gregory Frost, Ph.D., Halozyme's president and CEO. "MabThera is the standard of care for several serious forms of blood cancer and we expect this subcutaneous alternative could provide a compelling administration option."

This innovative technology may allow patients with NHL to receive MabThera in less than 10 minutes via a simple SC injection at their physician's office. Administration of SC MabThera means that patients with NHL undergoing induction therapy or completing two years of maintenance treatment with MabThera would have the greater convenience of being able to receive a much shorter drug administration, a compelling and welcome benefit.

Offering SC MabThera treatment outside of the IV infusion center or hospital setting could also reduce costs and potentially help to maximize the efficient use of hospital resources. Additional information about this Phase 3 SC MabThera clinical trial can be found at clinicaltrials.gov and roche-trials.com.

Halozyme-Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional three potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche will pay Halozyme additional milestones as well as royalties on future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

About Follicular Lymphoma and Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is diagnosed in approximately 356,000 people worldwide each year according to the WHO. Follicular lymphoma, a cancer of the blood, is a common type of NHL and accounts for about 20% of the new cases of NHL each year. NHL unfortunately remains incurable and patients ultimately relapse and require additional treatments.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche's biological therapeutics, including Herceptin® and MabThera®, and with Baxter BioScience to apply Enhanze technology to immunoglobulin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning, (i) Roche's progress under the collaboration, (ii) the potential achievement of various milestones, and (iii) the advantages of SC MabThera) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Senior Director, Investor Relations

SOURCE Halozyme Therapeutics, Inc.

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Celgene Announces Additional $1 Billion Share Repurchase Program

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG - News) today announced that the company's Board of Directors has authorized the repurchase of up to an additional $1 billion of the Company's common stock through December 2012. This authorization is in addition to the $500 million authorization announced on January 10, 2011. The $500 million program announced in April of 2009 has been fully utilized.

Purchases may be made in the open market or in privately negotiated transactions from time to time, as determined by Celgene’s management and in accordance with the requirements of the Securities and Exchange Commission. As of December 31, 2010, Celgene had 470,388,164 shares of common stock outstanding.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control. The Company’s actual results, performance, or achievements could be materially different from those projected by these forward-looking statements. The factors that could cause actual results, performance, or achievements to differ from the forward-looking statements are discussed in the Company’s filings with the Securities and Exchange Commission, such as the Company’s Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking statements.

Contact:

Celgene Corporation Jacqualyn A. Fouse, 908-673-9956 Sr. Vice President and Chief Financial Officer or Tim Smith, 908-673-9951 Director Investor Relations

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Genesis Biopharma, Inc. Announces Named President, CEO and Director

LOS ANGELES, Feb. 11, 2011 /PRNewswire/ -- Genesis Biopharma, Inc. (OTC Bulletin Board:GNBP.ob - News), a biotechnology company developing targeted cancer therapies, today announced that Anthony J. Cataldo has been named President and Chief Executive Officer. Mr. Cataldo succeeds Robert Brooke, who now serves as a strategic advisor to Genesis Biopharma. In addition, the Company named Michael Handelman as Chief Financial Officer, Treasurer and Secretary, succeeding Richard McKilligan.
Mr. Cataldo and Mr. Handelman have been appointed to the Company's Board of Directors. Mr. Brooke, Mr. McKilligan and Mark Ahn have resigned as members of the Genesis Biopharma Board. All of these changes are effective immediately.
"I'm looking forward to working with the Genesis Biopharma board to further the progress of our important cancer technology, and to develop new strategic opportunities to build shareholder value," said Mr. Cataldo. "Genesis Biopharma's targeted anti-CD55 monoclonal antibody technology has widespread clinical utility, as it neutralizes a key cancer defense mechanism that is over-expressed in more than 80% of tumors. The anti-CD55 technology could provide a safe alternative to toxic chemotherapy regimens, and has the potential to expand and improve the clinical utility of already approved antibody therapies as well as some novel agents in development."
Mr. Cataldo, age 58, has nearly two decades experience as a senior executive with publicly traded companies. He currently serves as the Chairman, Chief Executive Officer and a Director of Oxis International, Inc. (OTC Bulletin Board:OXIS.ob - News), positions he has held since March 2009. Oxis is engaged in the research, development and sale of products that counteract the harmful effects of oxidative stress. Previously, he served as non-executive Co-Chairman of the Board of MultiCell Technologies, Inc., a supplier of functional, non-tumorigenic immortalized human hepatocytes. Mr. Cataldo has also served as Executive Chairman of Calypte Biomedical Corporation, a biotechnology company involved in the development and sale of urine-based HIV-1 screening tests. Prior to that, he served as President and Chairman of the Board of Senetek, PLC, a biotechnology company involved in age-related therapies.
Michael Handelman, age 52, currently serves as the Chief Financial Officer of Oxis International. Before joining Oxis, he served as Chief Financial Officer and Chief Operating Officer of TechnoConcepts, Inc., a developing technology and manufacturing company. Prior to that, he was Chief Financial Officer of Interglobal Waste Management, Inc., a start-up manufacturing company. Mr. Handelman has also been Chief Financial Officer of the Los Angeles Kings, a National Hockey League franchise. He is a certified public accountant and holds a degree in accounting from the City University of New York.
About Genesis Biopharma, Inc.
Genesis Biopharma, Inc. is a development-stage biotechnology company engaged primarily in the development of targeted cancer therapies. For more information on the company, visit www.genesis-biopharma.com.
Forward-Looking Statements
The foregoing press announcement contains forward-looking statements that can be identified by such terminology as "expect," "potential," "suggests," "bodes," "may," "should," "could" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding future research, development and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the company's ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as of the date they are made. The company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.

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