Showing posts with label Million. Show all posts
Showing posts with label Million. Show all posts

Gilead Sciences, Inc. to Acquire Calistoga Pharmaceuticals for $375 Million


FOSTER CITY, Calif. & SEATTLE--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) and Calistoga Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of medicines to treat cancer and inflammatory diseases, today announced the signing of a definitive agreement pursuant to which Gilead will acquire Calistoga for $375 million. Calistoga could earn up to an additional $225 million if certain milestones are achieved. Gilead anticipates that the deal will close in the second quarter of 2011, subject to satisfaction of certain closing conditions, and plans to finance the acquisition through available cash on hand.

Calistoga has a portfolio of proprietary compounds that selectively target isoforms of phosphoinositide-3 kinase (PI3K). This pathway has been shown to be a central signaling pathway for cellular proliferation, survival and trafficking. The company’s lead product candidate, CAL-101, is a first-in-class specific inhibitor of the PI3K delta isoform. PI3K delta is preferentially expressed in leukocytes involved in a variety of inflammatory and autoimmune diseases and hematological cancers. CAL-101 is currently in Phase II studies as a single agent in patients with refractory indolent non-Hodgkin’s lymphoma (iNHL) and in combination with rituximab in treatment-naïve elderly patients with chronic lymphocytic leukemia (CLL). In addition to CAL-101, Calistoga Pharmaceuticals’ product development pipeline includes other selective PI3K inhibitors that are in preclinical development, and may have application in both oncology and inflammatory diseases.

“Oncology remains an area of significant unmet medical need and our increased understanding of the genetic basis of cancer allows for the development of disease specific targeted therapies. We are very encouraged by emerging clinical data for CAL-101, and this compound could represent an advance for the treatment of certain hematological cancers,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Building on the recent acquisitions of CGI Pharmaceuticals and Arresto Biosciences, this acquisition serves to further broaden Gilead’s pipeline and expertise in the areas of oncology and inflammation. We look forward to working with the team from Calistoga as we move these programs forward.”

“Our team at Calistoga Pharmaceuticals was the first to demonstrate the clinical benefit of targeting the delta isoform of PI3K as a novel treatment approach for patients with CLL and iNHL,” said Carol Gallagher, PharmD, Calistoga’s President and Chief Executive Officer. “We are pleased to join Gilead as they share our vision that more targeted therapies have the potential to improve the lives of patients with cancer and inflammatory diseases.”

Calistoga Pharmaceuticals' exclusive financial advisor for the transaction was J.P. Morgan Securities LLC while Wilson Sonsini Goodrich & Rosati, P.C. was its legal advisor.

About Calistoga Pharmaceuticals

Calistoga Pharmaceuticals, a privately-held company based in Seattle, Washington, is dedicated to developing targeted therapies to improve the health of patients with cancer or inflammatory diseases. For more information, visit the company’s website at: www.calistogapharma.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks that the acquisition of Calistoga will not be consummated as the transaction is subject to certain closing conditions and the transaction, if consummated, may not occur on the timelines currently anticipated. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to Gilead’s ability to successfully integrate the business and employees of Calistoga in Gilead’s business and Gilead’s ability to successfully advance Calistoga’s pipeline programs, including CAL-101. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contacts

Gilead Contacts: Gilead Sciences, Inc. Susan Hubbard, 650-522-5715 (Investors) Nathan Kaiser, 650-522-1853 (Media) or Calistoga Contact: Rathbun Communications, Inc. Julie Rathbun, 206-769-9219

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Galapagos NV Receives EUR4 Million in Milestones from Servier

MECHELEN, BELGIUM--(Marketwire - 02/08/11) - Galapagos NV (Euronext: GLPG) announced today that it reached milestones in its osteoarthritis alliance with Servier, resulting in payments in 2010 revenues totaling EUR4 million from Servier.

In July 2010, Servier and Galapagos announced their alliance to develop new medicines for the treatment of osteoarthritis. Galapagos is responsible for the discovery and development of new candidate drugs and Servier has an exclusive option to license these after the completion of Phase I clinical trials by Galapagos. To date, Galapagos has received a total of EUR11 million in payments from Servier under the alliance.

"We are delighted to reach the first milestones in the osteoarthritis alliance with Servier just six months after initiating the alliance," said Onno van de Stolpe, Galapagos' CEO. "The milestones announced today involve the optimization of molecules that have shown promise in altering the course of osteoarthritis."

"We are very pleased with the progress of our alliance with Galapagos so far. This is in line with Servier's commitment to develop disease-modifying drugs for sufferers of uncured diseases, such as OA, a debilitating disease that affects 12% of the world population, leading to severe and costly handicaps," said Emmanuel Canet, Head of R&D at Servier.

About Galapagos' osteoarthritis alliance with Servier

The alliance between Servier and Galapagos builds on novel osteoarthritis drug targets discovered by Galapagos through its proprietary platform. For any marketed products, Servier will have the rights to development, registration and commercialization, but Galapagos retains exclusive U.S. commercialization rights. Galapagos is also eligible to receive discovery, development, regulatory and other milestone payments that could reach EUR290 million, plus royalties upon commercialization of products outside the U.S. covered under the agreement.

About osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, typically affecting people aged 45 and older. It is a degenerative disease characterized by joint destruction and loss of cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage allows bones to glide over one another. It also absorbs energy from the shock of physical movement. In OA, the surface layer of cartilage breaks down and wears away. This allows bones under the cartilage to rub together, causing pain, swelling, and loss of motion of the joint. Over time, the joint may lose its normal shape. Also, bone spurs called osteophytes - may grow on the edges of the joint. Bits of bone or cartilage can break off and float inside the joint space. This causes more pain and damage. No currently available treatments prevent OA or even reverse or block the disease process. Treatment of OA involves weight control, exercise, and pain relief, most frequently with non-steroidal anti-inflammatory drugs (NSAIDs) that relieve the symptoms without changing the course of the underlying disease. Many OA patients have pain that persists despite these measures and often then have to undergo costly surgical procedures to replace their damaged joints. It is expected that with the aging of the population, more individuals will be prone to develop OA. As mobility of seniors is of high importance to maintaining a high quality of life, preventing the severity of OA is seen as an immense clinical need over the next decade.

About Servier

Servier is a privately-run research based pharmaceutical company with a 2010 turnover of EUR3.7 billion. Servier is dedicating 25% of its turnover to Research & Development in cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees. More info at: www.servier.com

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing one of the largest pipelines in biotech, with seven clinical and over 50 small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to receive up to EUR2.5 billion in downstream milestones, plus royalties. The Galapagos Group has over 800 employees and operates facilities in seven countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com

Cautionary note regarding forward-looking statements

This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Galapagos NV via Thomson Reuters ONE

CONTACTS

Servier Laboratories Servier Communication Department Tel: +33 1 55 72 40 82 Email Contact Galapagos NV Onno van de Stolpe CEO Tel: +31 6 2909 8028 Email Contact Elizabeth Goodwin Director, Investor Relations Tel: +31 6 2291 6240 Email Contact

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Pro-Pharmaceuticals, Inc. Receives Final Tranche of Funding from Federal Grant; Raises Cash Position to $8 Million

NEWTON, Mass.--(BUSINESS WIRE)-- Pro-Pharmaceuticals, Inc. (OTC:PRWP.ob - News), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has received the final tranche of $234,000 of the $489,000 in federal grant funding under the Qualifying Therapeutic Discovery Project (“QTDP”) Program.

In addition to the federal grants, since filing the third quarter report on Form 10-Q on November 12th, 2010, the Company has issued approximately 4.9 million common shares from warrant and stock option exercises for cash proceeds of approximately $2.8 million and raised approximately $2.25 million from the sale of Series C Preferred stock, resulting in a current cash position of approximately $8.1 million, which may fund core operations into the second half of 2012.

The criteria for QTDP grants were:

* Unique technology * Promise of significant advance in the treatment of the disease * Carrying out research protocols for the purpose of securing federal government approval by the FDA.

Pro-Pharmaceuticals submitted two grant applications; one for its DAVANAT® anti-cancer compound, which is entering a Phase III clinical trial to treat colorectal cancer, and a second grant for its GR and GM Series of anti-fibrotic, cirrhosis compounds, which have reversed liver fibrosis/cirrhosis in pre-clinical studies. The only treatment for late stage fibrosis or cirrhosis is liver transplantation.

The Company’s polysaccharide compounds target Galectin receptors that have been shown by internationally recognized researchers to be involved in the development of cancer cells. Blocking these receptors also has been shown to reverse the formation of fibrotic tissue in diseased livers.

“We believe the QTDP grants for DAVANAT®, our anti-cancer compound, and for GM and GR Series of anti-fibrosis compounds, validate our drug development programs and approach for treating acute and chronic diseases with polysaccharides,” said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. “The QTDP Program seeks to accelerate development of compounds that are novel and show great promise of success as treatments for disease. Our drug development programs were awarded the grants because our polysaccharides are novel, non-toxic, and because the Galectins they target are instrumental in the pathology of many diseases.”

About DAVANAT®

DAVANAT®, the Company's lead product candidate, is a polysaccharide polymer that targets Galectin receptors on cancer cells and interferes with their activity. Peer-reviewed studies have demonstrated that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis, tumor metastasis and give the tumor the ability to evade the immune system. To date, DAVANAT® has been administered to approximately 100 cancer patients. Data from a Phase II trial for end-stage colorectal cancer patients showed that DAVANAT® in combination with 5-FU extended median survival by 46% compared with the best standard of care as determined by the patients’ physicians. Clinical trial results also showed that patients experienced fewer serious adverse side effects of the chemotherapy and required less hospitalization, resulting in an improved quality of life.

About GM and GR Series of Fibrosis Compounds

The GM and GR series of compounds are first-in-class, novel carbohydrate compounds that significantly reduced collagen expression and reversed fibrosis in animal models. Uncontrolled collagen expression is a pathological process that occurs during the fibrotic process, affecting various organs leading to scar tissue. Chemical toxicity, microbial infection or physical injury cause hepatic, renal and other types of fibrosis. Carbohydrate polymers were synthesized and screened to inhibit collagen production in in-vivo and in-vitro fibrosis models.

Pro-Pharmaceuticals, Inc.

Pro-Pharmaceuticals, OTC: PRWP, the leader in the field of Galectin therapeutics, is engaged in the discovery, development and commercialization of therapeutics that target Galectin receptors for advanced treatment of cancer and fibrosis. Initially, the product pipeline is focused on increasing the efficacy and decreasing the toxicity of chemotherapy drugs. The Company is headquartered in Newton, Mass. Additional information is available at www.pro-pharmaceuticals.com.

FORWARD LOOKING STATEMENTS: Any statements in this news release about future expectations, plans and prospects for the Company constitute forward-looking statements as defined in the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including statements about clinical trials and core operations funding, are based on management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements. We caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements as a result of various factors and not place undue reliance on forward-looking statements.

More information about those risks and uncertainties is contained and discussed in the Company’s most recent quarterly or annual report and in the Company’s other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company’s views as of the date of this news release and should not be relied upon to represent the Company’s views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company’s views to change, the Company disclaims any obligation to update such forward-looking statements.

DAVANAT is a registered trademark of Pro-Pharmaceuticals.

Contact:

Pro-Pharmaceuticals, Inc. Anthony D. Squeglia, 1-617-559-0033 squeglia@pro-pharmaceuticals.com

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UCB Pharma and PDL BioPharma, Inc. Resolve Patent Disputes; to Pay $10 Million

BRUSSELS and INCLINE VILLAGE, Nev., Feb. 8, 2011 /PRNewswire/ -- UCB SA (Euronext Brussels: UCB), on behalf of its affiliate UCB Pharma S.A. (UCB), and PDL BioPharma, Inc. (Nasdaq:PDLI - News) (PDL) today jointly announced that the companies have entered into a definitive settlement agreement that resolves all legal disputes between them, including those relating to UCB's pegylated humanized antibody fragment, Cimzia (certolizumab pegol), and PDL's patents known as the Queen et al. patents.

Under the settlement agreement, PDL provided UCB a covenant not to sue UCB for any royalties regarding UCB's Cimzia product under the Queen patent portfolio in return for a lump sum payment of US$10 million and the mutual resolution of other disputes between the two companies, including two pending patent interferences before the United States Patent and Trademark Office and a patent opposition in the European Patent Office. No additional payments will be owed by UCB to PDL under the Queen patents in respect of Cimzia sales for any indication and the sale of a product in development that may or may not be approved within the term of the Queen patents.

About Cimzia

Cimzia® is a pegylated, humanized TNFa (tumor necrosis factor alpha) antibody fragment. The U.S. Food and Drug Administration has approved Cimzia for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Cimzia in combination with methotrexate (MTX), is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease modifying antirheumatic drugs including MTX. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia is a registered trademark of UCB.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 000 people in about 40 countries, the company generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).

About PDL BioPharma

PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases. PDL is focused on maximizing the value of its antibody humanization patents and related assets. The Company receives royalties on sales of a number of humanized antibody products marketed by leading pharmaceutical and biotechnology companies today based on patents which expire in late 2014. For more information, please visit www.pdl.com.

NOTE: PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.

Forward Looking Statements

This press release contains forward-looking statements. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements, including because UCB or PDL fail to timely fulfill their respective obligations under the settlement agreement. PDL and UCB expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in their respective expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

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Medicis and Anacor Pharmaceuticals, Inc. Enter $160 Million Research and Development Collaboration for the Treatment of Acne

SCOTTSDALE, Ariz. and PALO ALTO, Calif., Feb. 10, 2011 (GLOBE NEWSWIRE) -- Medicis Pharmaceutical Corporation (NYSE:MRX - News) and Anacor Pharmaceuticals, Inc. (Nasdaq:ANAC - News) today announced that the two companies have entered into a research and development agreement to discover and develop boron-based small molecule compounds directed against a target for the potential treatment of acne.

Under the terms of the agreement, Anacor will receive a $7 million upfront payment from Medicis and will be primarily responsible for discovering and conducting early development of product candidates which utilize Anacor's proprietary boron chemistry platform. Medicis will have an option to obtain an exclusive license for products covered by the agreement. Anacor will be eligible for future research, development, regulatory and sales milestones of up to $153 million, as well as high single-digit to low double-digit royalties on sales by Medicis. Medicis will be responsible for further development and commercialization of the licensed products on a worldwide basis.

"We are pleased to announce this important collaboration with Anacor," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "Anacor and its scientists are well respected in the scientific community, and Medicis is proud to be among other significant organizations who have partnered with them to explore the pharmaceutical development of the Anacor boron chemistry platform. We will together be working hard to achieve breakthroughs with this proprietary technology in the treatment of acne."

"We have demonstrated that boron-based chemistry is productive in creating novel small molecule therapeutics, and we are excited to work with Medicis to apply this technology to the development of a unique, patented treatment for acne," said David Perry, Anacor's Chief Executive Officer. "With our technology and Medicis' expertise in developing and commercializing pharmaceuticals, we hope this collaboration will result in innovative products to help the patients who suffer from this condition."

About Medicis

Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.

The Company's products include the brands DYSPORT(R) (abobotulinumtoxinA) 300 Units for Injection, PERLANE(R) Injectable Gel, PERLANE-L(R) Injectable Gel with 0.3% Lidocaine, RESTYLANE(R) Injectable Gel, RESTYLANE-L(R) Injectable Gel with 0.3% Lidocaine, DYNACIN(R) (minocycline HCl Tablets, USP), LOPROX(R) (ciclopirox) Gel 0.77% and Shampoo 1%, PLEXION(R) (sodium sulfacetamide 10% and sulfur 5%) Cleanser, Cleansing Cloths and SCT, SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, TRIAZ(R) (benzoyl peroxide) 3%, 6% and 9% Cleansers, Pads and Foaming Cloths, VANOS(R) (fluocinonide) Cream 0.1%, ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder, the LIPOSONIX(TM) system1 and the over-the-counter brand ESOTERICA(R).

For more information about Medicis, please visit the Company's website at www.Medicis.com. Printed copies of the Company's complete audited financial statements are available free of charge upon request.

Medicis Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. Several of these risks are outlined in the Company's most recent annual report on Form 10-K for the year ended December 31, 2009, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.

NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company or by visiting www.Medicis.com. All trademarks are the property of their respective owners.

About Anacor Pharmaceuticals

Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor has discovered five clinical compounds which are currently in development, including its three lead programs: AN2690, a topical antifungal for the treatment of onychomycosis; AN2728, a topical anti-inflammatory PDE-4 inhibitor for the treatment of psoriasis; and GSK 2251052, or GSK '052 (formerly referred to as AN3365), a systemic antibiotic for the treatment of infections caused by Gram-negative bacteria, which has been licensed to GlaxoSmithKline under the companies' research and development agreement. In addition, Anacor is developing AN2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections, and AN2898 as a topical anti-inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. For more information visit www.anacor.com.

Anacor Forward-Looking Statements

This release contains forward-looking statements, including statements regarding the success of and any payments that may result from Anacor's collaboration with Medicis, as well as other matters that are described in Anacor's Registration Statement on Form S-1 filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.

1 The LIPOSONIX(TM) system is not approved or cleared for sale in the U.S.

Contact:

Medicis Kara Stancell (media) (480) 291-5454 Sean Andrews (investors) (480) 291-5854 Anacor DeDe Sheel (650) 543-7575

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GlaxoSmithKline Said to Pay $250 Million to Resolve Avandia Suits


GlaxoSmithKline (GSK) Said to Pay $250 Million to Resolve Avandia Suits
2/8/2011

Philadelphia Business Journal -- GlaxoSmithKline has settled 5,500 cases related to its diabetes drug Avandia for $250 million, or an average of $46,000 each, the Philadelphia Inquirer reports in a Bloomberg story.

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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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Versartis, Inc. Completes $21 Million Series B Financing

MOUNTAIN VIEW, CA--(Marketwire - 02/16/11) - Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, today announced completion of a $21 million Series B financing. The funding was led by New Leaf Venture Partners and Advent Venture Partners' Advent Life Sciences fund also joined the round along with existing investors Index Ventures and Amunix. Versartis plans to use the proceeds primarily to conduct clinical trials of its lead product, VRS-317, for growth hormone deficiency (GHD) in both adult and pediatric patients. VRS-317 is a once monthly form of recombinant human growth hormone (rhGH).

Effective with the close of the financing, Versartis announced the expansion of its Board of Directors to five members: Srini Akkaraju, M.D., Ph.D., Managing Director, New Leaf Venture Partners; Kevin Johnson, Ph.D., Partner, Index Ventures; Shahzad Malik, General Partner, Advent Venture Partners; Willem "Pim" Stemmer, Ph.D., Chief Executive Officer, Amunix; and Jeffrey L. Cleland, Ph.D., Chief Executive Officer, Versartis, Inc.

Commenting on New Leaf Venture Partners' new investment, Srini Akkaraju, M.D., Ph.D., said, "Based on the track record of Versartis management along with the encouraging preclinical data seen to date, we are optimistic that the potential of VRS-317 and its once-monthly dosing regimen address key unmet needs in the treatment of patients with growth hormone deficiency."

"This is an exciting time to invest in Versartis," added Shahzad Malik, General Partner, Advent Venture Partners. "Its focus on applying the proprietary XTEN technology to recombinant human growth hormone provides a significant opportunity to expand the current market for rhGH products."

Preclinical data previously presented have demonstrated that VRS-317 provides comparable biological activity and safety to daily rhGH with a lower total monthly dose of rhGH. Versartis currently plans to begin enrollment in a multi-center Phase 1 study in adult GHD patients in the first quarter of 2011.

About Versartis Versartis, Inc. is a biotechnology company developing therapeutics for the treatment of endocrine disorders. The company's lead product candidate is VRS-317, a once monthly form of human growth hormone. Versartis is pursuing the development of new therapeutic proteins utilizing the Amunix novel half-life extension XTEN technology. XTEN is a novel hydrophilic sequence of natural amino acids and is expressed as a fusion protein with a therapeutically active peptide or protein. New compounds developed by Versartis using the XTEN technology are expected to provide improved therapeutic outcomes such as enhanced efficacy/compliance, fewer side effects, prolonged half-life (up to monthly dosing), as well as low-cost production and enhanced stability. Further information on Versartis can be found at www.versartis.com.

About NLV Partners New Leaf Venture Partners is a leader in healthcare technology venture investing. Our investment professionals bring a unique blend of technological, clinical, and operational experience to our investments. We work closely with our entrepreneurs to help build successful portfolio companies. We focus primarily on later stage biopharmaceutical products, early stage medical devices, and laboratory infrastructure technologies.

New Leaf currently manages $1.1 billion in assets. This includes our newest fund, New Leaf Ventures II, L.P., which closed with commitments of $450 million in October 2007, New Leaf Ventures I, L.P. and the healthcare technology portfolio of the Sprout Group, one of the oldest U.S. venture capital fund groups. For more information please visit http://www.nlvpartners.com.

About Advent Venture Partners Advent Venture Partners is one of Europe's most established growth and venture capital firms, investing in technology and life sciences businesses run by great teams that want a pragmatic and well-connected partner by their side.

The Advent life sciences team is a leader in European life sciences venture capital. Its investments include: PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; Cellnovo, a biomedical device company developing a revolutionary mobile insulin pump system; EUSA Pharma, a rapidly growing transatlantic speciality pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (ALGETA.OL), an oncology company developing treatments for bone metastases and disseminated tumour types.

In November 2010, Advent announced the final close of the first life sciences-focused fund raised by the firm, Advent Life Sciences. www.adventventures.com

Contacts: Corporate Paul Westberg SVP Business Development Ph: 650 963-8585 Email: Email Contact Media Debra Bannister Corporate Communications Ph: 631 659-3735 Email: Email Contact

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Conatus Pharmaceuticals Inc. Completes $20 Million Series B Private Placement Financing

SAN DIEGO, Feb. 11, 2011 /PRNewswire/ -- Conatus Pharmaceuticals Inc. today announced the closing of a $20 million Series B Preferred Stock private placement financing. This financing was led by new investor, AgeChem Venture Fund of Montreal, Canada, and included participation by existing investors; Aberdare Ventures, Advent Venture Partners, Bay City Capital, Gilde Healthcare Partners, and Roche Venture Fund. Conatus will use the proceeds to advance the clinical development of CTS-1027, a novel clinical-stage drug candidate the Company has licensed from F. Hoffman-La Roche, Ltd. and is the subject of multiple Phase 2 clinical trials in hepatitis C (HCV)-infected patients.
As part of the financing, Louis Lacasse from AgeChem will join the Conatus Board of Directors. "We are very excited about joining such an elite group of investors to support the development of CTS-1027 which we believe could be a blockbuster drug for the treatment of HCV infections," said Louis Lacasse.
Continuing Board Directors are Paul Klingenstein from Aberdare Ventures, Shahzad Malik, M.D., from Advent Venture Partners, William Gerber, M.D., from Bay City Capital, and Marc Perret from Gilde Healthcare, and independent directors, David Hale and Hal Van Wart, Ph.D. Steven J. Mento, Ph.D., Co-founder, President and CEO of Conatus, will continue as Chairman of the Board.
Concurrent with the first closing of the Series B financing, Conatus also converted promissory bridge notes into Series B preferred stock.
The Series B financing will remain open for an additional period as other potential investors conclude their diligence.
"This financing enables Conatus to expand the clinical development of CTS-1027 as a cell-based antiviral for the treatment of HCV infections. We believe that CTS-1027 represents a novel approach to treating HCV disease and look forward to developing this drug candidate in the HCV-null responder population in combination with the existing standard of care drugs. We also believe that CTS-1027 may be an ideal candidate for use in combination with new antiviral drugs in future all oral treatments for HCV," said Steven J. Mento Ph.D.
Conatus Pharmaceuticals Inc. is a privately-held biopharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease and oncology. Conatus' lead drug candidate, CTS-1027 is in multiple Phase 2 clinical trials for the treatment of hepatitis C virus (HCV). Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer. For additional information, please visit www.conatuspharma.com.
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