Graceway Pharmaceuticals obtained commercialization rights to three dermatological molecules from Pfizer. The acquisition and license agreement includes related transferred or licensed intellectual properties.

This transaction is part of Pfizer’s plan to out-license noncore programs; the firm identified CNS diseases, oncology, and cardiovascular diseases as its focus. Pfizer continues to be responsible, however, for performing developmental and clinical services for these three molecules.

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Of the acquired therapeutic candidates, two target the treatment of oily skin and acne: early-stage stearoyl CoA desaturase 1 inhibitor and Phase II cholesterol-acyltransferase (ACAT) inhibitor. The latter reportedly offers a new mechanism of action to address these common conditions and is understood to work by reducing skin surface sebum production. In addition, Graceway will acquire an activin-like kinase 5 (ALK-5) inhibitor, currently in early preclinical development for the reduction of surgical and traumatic scar formation.

Source: GEN News

Popularity: 3% [?]

AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, announced today that it has completed its previously announced registered direct offering of US$10 million of units comprised of common shares and common share purchase warrants to certain institutional investors. AEterna Zentaris received net proceeds of approximately US$9.25 million after deducting placement agent fees and other offering expenses. All of the common shares and warrants were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including clinical development of the Company’s leading oncology and endocrinology compounds.

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Dr. Juergen Engel, Ph. D., President and CEO of AEterna Zentaris stated, “We are very pleased with this vote of confidence from targeted specialized institutional investors. In addition, completing this financing provides us with additional funds that will help us to further strengthen our promising oncology pipeline.”

As of June 24, 2009 and after issuing 5,319,149 common shares at the closing of the offering, the Company had 58,506,619 common shares issued and outstanding.

A shelf registration statement relating to the common shares and warrants issued in the offering (and the common shares issuable upon exercise of the warrants) has been filed with the Securities and Exchange Commission (the “SEC”) and has been declared effective. A prospectus supplement relating to the offering was filed with the SEC. Copies of the prospectus supplement and accompanying prospectus may be obtained directly from AEterna Zentaris Inc., 1405 du Parc-Technologique Boulevard, Quebec City, Canada G1P 4P5. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of AEterna Zentaris’ common shares or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

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Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (Nasdaq: RODM – News), acted as the exclusive placement agent for the transaction.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are requested by a governmental authority or applicable law.

Source: AEterna Zentaris Inc.

Popularity: 4% [?]

GlaxoSmithKline entered into an agreement with Dr. Reddy’s to develop and market select products across emerging markets outside India, Dr. Reddy’s announced on Monday. As part of the partnership, which is effective immediately and covers generics and differentiated formulations, GlaxoSmithKline will gain access to Dr. Reddy’s portfolio and future pipeline of more than 100 branded pharmaceuticals in therapeutic segments such as diabetes, cardiovascular, gastroenterology, pain management and oncology.

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Under the terms of the deal, the products will be manufactured by Dr. Reddy’s and will be licensed and supplied to GlaxoSmithKline in various markets, such as Latin America, Asia Pacific, Africa and the Middle East. Revenues will be reported by GlaxoSmithKline and will be shared with the India-based company as per agreed terms, which were not disclosed. The drugmakers will also co-market products in certain markets.

According to a GlaxoSmithKline spokesperson, the first products are expected to reach the market in the second half of the year, with Mexico likely to be the first country. The companies have unspecified branded generic versions of central nervous system and cardiovascular drugs they are looking to launch in Mexico, he remarked.

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GlaxoSmithKline’s president for emerging markets, Abbas Hussain, explained that the agreement is “another significant step forward in our strategy to grow and diversify [our] business in emerging markets.” The drugmaker recently announced that it would launch a joint venture with Shenzhen Neptunus in China to develop and manufacture influenza vaccines, and last year it reached a deal to license, market and distribute branded generic drugs in emerging markets with Aspen Pharmacare. GlaxoSmithKline also announced last year the purchase of Bristol-Myers Squibb’s mature products unit in Egypt.

Source: FirstWord

Popularity: 3% [?]

Daiichi Sankyo’s head of European operations, Reinhard Bauer, commented that the drugmaker is planning to invest in biotechnology acquisitions in order to strengthen its oncology portfolio, Bloomberg reported. The drugmaker also intends to use part of a $5-billion investment to expand into new markets and broaden its cardiovascular portfolio.

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Bauer explained that “with our existing portfolio and existing markets we can grow to a business volume on our own of 800 million euros ($1.1 billion).” However, he noted that if the drugmaker wants to reach its sales goal of 1 billion euros ($1.4 billion) for Europe in 2011, it needs to “consider acquiring [itself] into new markets where [it is] not yet present.” Daiichi Sankyo will target acquisitions that offer the potential to fill current gaps in Eastern Europe and Scandinavia, according to the executive.

In addition, Bauer indicated that Daiichi Sankyo has ruled out a purchase of Nycomed or Solvay’s pharmaceuticals unit based on an evaluation of the companies’ pipelines and development projects. “They do not really have a synergy with our business focus of oncology or cardiology,” he noted.

Source: FirstWord

Popularity: 4% [?]

AstraZeneca and Merck & Co. on Monday announced an alliance to research the combination of investigational compounds AZD6244 from AstraZeneca and MK-2206 from Merck. The companies noted that the agreement marks “the first time two large pharmaceutical companies have established a collaboration to evaluate the potential for combining candidate molecules at such an early stage of development.”

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Under the terms of the deal, the drugmakers will work together to evaluate co-administration of the compounds in a Phase I trial for the treatment of solid cancer tumours, and following the trial AstraZeneca and Merck will consider opportunities for further clinical development. All development costs incurred as part of the agreement will be shared jointly.

AZD6244, which blocks the MEK pathway, is currently in mid-stage studies for several tumour types and has been tested in patients with skin, colorectal and lung cancers, while MK-2206 inhibits the AKT pathway and has undergone Phase I testing on solid tumours. The combined compounds would work on “two critical pathways in oncogene signalling,” explained Gary Gilliland, franchise head for oncology at Merck Research Laboratories.

Source: FirstWord

Popularity: 3% [?]

Sanofi-aventis announced Wednesday that the company entered into an agreement to purchase BiPar Sciences in a transaction worth as much as $500 million. As part of the deal sanofi-aventis gains access to the US biotechnology company’s potential first-in-class oncology treatment BSI-201, a Poly ADP-Ribose Polymerase (PARP) inhibitor, currently in mid-stage testing for the treatment of metastatic triple-negative breast cancer, ovarian cancer and other malignancies.

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“The acquisition of BiPar, one of the pioneers for novel tumour-selective therapies, is a further step in our company’s goal to focus on new approaches to strengthen our oncology R&D portfolio,” stated sanofi-aventis CEO Chris Viehbacher. The final purchase price of the deal, which is expected to close during the current quarter, depends on potential milestone payments associated with the development of BSI-201. Fiske analyst Peter Cartwright noted that “risk-sharing seems to be the preferred mantra for pharmaceutical executives these days.”

Helvea analyst Karl-Heinz Koch commented that “PARP inhibitors are a promising emerging new product class in the area of oncology and may improve [sanofi-aventis'] standing in what has been a traditional stronghold for the company, which is at risk of being undermined due to a lack of innovative product flow at a time of important patent losses.”

The news marks the company’s third acquisition deal this month, following agreements to purchase generic drugmakers Medley in Brazil and Laboratorios Kendrick in Mexico. The acquisitions match “perfectly…with CEO Viehbacher’s strategy to do disciplined small- and mid-sized acquisitions in the generics and biologics sector,” said Thomas Maul of DZ Bank.

Source: FirstWord

Popularity: 4% [?]

Bayer announced Tuesday that the company entered a new strategic agreement with Genzyme under which Bayer agreed to transfer its haematological oncology portfolio to Genzyme. The deal includes leukaemia treatment Campath (alemtuzumab), anti-infective drug Leukine (sargramostim) and chemotherapy product Fludara (fludarabine).

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According to the terms of the alliance, Bayer will transfer to Genzyme global development and distribution rights for Campath for the treatment of B-cell chronic lymphocytic leukaemia, and give Genzyme exclusive worldwide licenses for Leukine and Fludara for all present and future indications. In return, Bayer will receive as much as $650 million from Genzyme in milestone and royalty payments.

In addition, Bayer will return to Genzyme the worldwide rights to Campath, but the companies will continue an established partnership to co-develop the drug as a potential treatment for multiple sclerosis. Should the drug eventually be approved for the MS indication, Bayer said that it “has the option and will exercise its right” to co-promote the treatment globally for that use, and would be eligible to receive up to $1.25 billion in royalties from Genzyme over a 10-year period.

Bayer Chairman Arthur Higgins commented that the deal, which is expected to close in the second quarter, “assures that [the companies] are better aligned to maximise the opportunity for alemtuzumab in both oncology and multiple sclerosis, and frees up resources to accelerate the development” of Bayer’s oncology pipeline. The deal is expected to enable Bayer to focus its resources in oncology on Nexavar (sorafenib) and “additional product developments.”

Bayer estimated that approximately 330 positions globally at Bayer will be affected by the agreement, including around 250 in the US. The two companies “will work together on a process to identify opportunities for continued employment for individuals in these positions as the business and manufacturing operations transition into Genzyme,” Bayer stated.

Source: FirstWord

Popularity: 4% [?]

Human Genome Sciences, Inc. (Nasdaq: HGSI – News) and Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, today announced that they have entered into a collaboration to discover, develop and commercialize therapeutic monoclonal antibodies in the fields of oncology and immunology that specifically target antigens discovered by HGS.

“The rapid commercialization of our late-stage compounds continues to be the priority focus of HGS. At the same time, we also remain committed to advancing our earlier and mid-stage programs in development to ensure sustainable growth well into the future,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We look forward to collaborating with Morphotek to develop targeted new therapies based on our discoveries and extensive intellectual property estate.”

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Under the terms of the agreement, Morphotek will be responsible for validating targets discovered through genomic research and provided by HGS, generating and developing all monoclonal antibody candidates using proprietary Morphotek technologies, and conducting early preclinical proof of concept studies. With respect to each antibody candidate, HGS and Morphotek will have the right to opt in to participate in development and commercialization. Under certain circumstances, HGS and Morphotek may share research and development, manufacturing and commercialization costs. Financial and other specific terms were not disclosed.

“Our proprietary technologies have been applied successfully to a variety of biological targets, and we look forward to collaborating with Human Genome Sciences to apply our antibody technology to a range of novel targets that stem from HGS’s genomic discovery research,” said Nicholas Nicolaides, Ph.D., President and CEO of Morphotek. “This agreement is a continuation of our business model of leveraging access to targets from collaborators that have identified them using their internal expertise/technologies, applying Morphotek’s technologies to develop lead antibodies and then through active collaboration with our partners validating the therapeutic potential of our antibodies in preclinical and if warranted clinical studies.”

About the HGS New Targets Initiative

HGS has a rich heritage of scientific discovery that has produced a large intellectual property estate and a library of thousands of therapeutic and diagnostic targets. Over the past three years, HGS has conducted a careful review and selected approximately 50 targets for further research and potential development. HGS plans to develop the selected targets through co-development or research collaborations, including the agreement with Morphotek announced today, as well as through its own internal research.

About Morphotek

Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, is a biopharmaceutical company specializing in the development of protein and antibody products through the use of novel and proprietary technologies. These technologies have been successfully applied to a variety of molecules that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit www.eisai.com.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer.

The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, Albuferon® (albinterferon alfa-2b) for hepatitis C and LymphoStat-B® (belimumab) for lupus. Albuferon has now completed Phase 3 development, and the filing of global marketing applications is expected in fall 2009. Two Phase 3 clinical trials of LymphoStat-B are ongoing, with results expected in July and November 2009.

In January 2009, HGS began delivery of 20,000 doses of ABthrax(TM) (raxibacumab) to the U.S. Strategic National Stockpile for use in the event of an emergency for the treatment of inhalation anthrax. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody HGS-ETR1 and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development as a potential treatment for coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development as a potential treatment for type 2 diabetes.

For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to clinical_trials@hgsi.com or by calling HGS at (301) 610-5790, extension 3550.

HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.

HGS Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, while the Company has begun shipment of ABthrax to the U.S. Strategic National Stockpile, the Company will continue to face risks related to acceptance of future shipments and FDA’s approval of the Company’s Biologics License Application for ABthrax, if and when it is submitted. If the Company is unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Source: Human Genome Sciences, Inc.

Popularity: 4% [?]

GPC Biotech and Agennix announced that the companies agreed to a proposed merger deal that is anticipated to close by the end of this year. The agreement values GPC shares at 1.26 euros ($1.58), which is a 22-percent premium over its share price on February 17.

GPC Biotech CEO Bernd Seizinger commented that the combined company will continue to develop Agennix’s oncology drug talactoferrin, which is in late-stage testing in non-small-cell lung cancer. In addition, the companies stated that they will focus on other cancer therapies, including the multi-targeted kinase inhibitor RGB-286638. The investigational compound is in Phase I development for advanced solid tumours.

Source: FirstWord

Popularity: 3% [?]

Based on clinical trials, we know a fair amount about drugs on the market. But how much don’t we know?

It’s been a long-running controversy, and has come to a head in recent years after a string of drug-safety scandals. There are efforts to get drugmakers to disclose more trial results, such as a rule requiring them to register trials and provide results on clinicaltrials.gov. But today’s WSJ Science Journal column presents some recent stats that bring the issue into sharp relief.

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Some highlights:

• Last month, analysts led by an expert at the University of California in San Francisco checked 164 clinical trials testing 33 different drugs submitted for FDA approval from 2001 to 2002. One in four had yet to be published. Almost all of the unpublished findings made the drug in question look bad.
• In September, some UCSF folks reviewed 900 FDA filings involving 90 new drugs. More than half of the clinical trials were still unpublished 5 years after the drugs had been approved.
• Earlier this year, doctors at the University of Washington reported in the journal Oncology that only one in five cancer clinical trials ever is disclosed.
• Earlier this fall, researchers at the State University of New York reviewed 1,835 clinical research articles from four leading otolaryngology journals and reported that a third of them failed to mention any side effects at all.

For a taste of the controversies that come up, take a look at some of our past posts about a negative study of Pfizer’s Neurontin, unpublished negative studies of depression, and of course, the brouhaha early this year after Merck and Schering-Plough delay in releasing findings about cholesterol-drug Vytorin that turned out to be unflattering. Those results were published ultimately in the New England Journal of Medicine in April.

Source: The Wall Street Journal

Popularity: 3% [?]