|RxNews Recap for Monday 02-01-10. Array (ARRY) jumps afterhours. InterMune (ITMN) see's heavy options activity|
|By Mary Davila|
|Monday, 01 February 2010 19:05|
Array BioPharma Inc.(Nasdaq: ARRY) shares soared in after hours trading today as the company reported financial results for the second quarter of fiscal 2010 that were significantly above consensus estimates. Shares of Array topped Nasdaq's after hour sessions most advanced list, jumping over 8% with 243,151 shares traded.
Array reported revenue of $9.6 million for the second quarter of fiscal 2010, that was compared to revenue of $7.7 million for the same period in fiscal 2009.
The biopharmaceutical company, which focuses on the discovery, development, and commercialization of small molecule drugs to treat patients with cancer, inflammatory, and metabolic diseases reported a net loss of $21.8 million, or ($0.44) per share, for the second quarter, compared to a net loss of $37.8 million, or ($0.79) per share, for the second quarter in fiscal 2009. Array ended the second quarter of fiscal 2010 with $115 million in cash, cash equivalents and marketable securities.
Revenue for the six-month period ended December 31, 2009 was $17.5 million, compared to revenue of $13.4 million for the same period in fiscal 2009. Net loss for the six months ended December 31, 2009, was $46.6 million, or ($0.96) per share, compared to a net loss of $71.5 million, or ($1.50) per share, reported in the same six-month period in fiscal 2009.
The loss was narrower than expected, helped by payments from its drug partnerships. Array had inked a partnership deal with Amgen Inc (Nasdaq: AMGN) for the development and marketing of its type 2 diabetes drug last December.
“We are delighted to partner with Amgen on our type 2 diabetes program, including AMG 151 / ARRY-403, which provided a $60 million up-front payment with additional potential milestones of $666 million and a double-digit royalty,” said Robert E. Conway, Chief Executive Officer. “We continued to implement our partnering strategy with our Amgen deal, which significantly added to our cash balance and reduced our burn. Our partnerships, which include seven Array-invented drugs in clinical trials, provide Array with significant upside of $1.9 billion in potential milestones and royalties that range up to 15 percent. As a result of our partnering efforts, we are revising our guidance for the second half of the fiscal year, increasing our revenue and reducing our loss per share.”
Other news from the after hours session:
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) after the bell announced the execution of a license agreement for elvucitabine, the Company nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of both hepatitis B virus (HBV) infection and human immunodeficiency virus (HIV) infection with GCA Therapeutics, Ltd. (GCAT) of Jersey City, New Jersey. The exclusive license grants GCAT the right, through its Chinese joint venture with Tianjing Institute of Pharmaceutical Research, to clinically develop and commercialize elvucitabine in mainland China, Hong Kong, and Taiwan. In Phase 2 clinical trials elvucitabine has demonstrated to be safe and well tolerated and to be efficacious in both HBV and HIV infected patients. Shares were trading higher in the after hours session.
MannKind Corporation (Nasdaq: MNKD) reported financial results after the bell for the fourth quarter and year ended December 31, 2009. For the fourth quarter of 2009, total operating expenses were $55.8 million, compared to $81.8 million for the fourth quarter of 2008. Research and development (R&D) expenses were $43.1 million for the fourth quarter of 2009 compared to $68.8 million for the same quarter in 2008, a decrease of $25.7 million. This 37% decrease was primarily due to reduced costs associated with the clinical development of AFREZZA™ as the Company completed its pivotal AFREZZA trials in 2008, including decreased raw material purchases and clinical supplies costs, offset by a loss on disposal of fixed assets of $12.8 million. General and administrative (G&A) expenses decreased by $0.3 million to $12.7 million for the fourth quarter of 2009 compared to $13.0 million in the fourth quarter of 2008.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced after the bell that it has signed a definitive agreement to acquire Finnzymes, a well-recognized provider of integrated tools for molecular biology analysis, including reagents, instruments, consumables and kits. Headquartered in Espoo, Finland, Finnzymes has 90 employees and generated revenue of $20 million in 2009.
Finnzymes provides comprehensive solutions for high-performance polymerase chain reaction (PCR), reverse transcription-PCR (RT-PCR) and real-time quantitative PCR (qPCR). The company’s expertise in DNA polymerases has led to significant increases in the performance of these enzymes, making the PCR process faster and more accurate. The ability to quickly and reproducibly amplify and quantify particular DNA sequences benefits a variety of applications, including basic genomic research, genetic testing, forensics and food testing.
In news from earlier in the day:
Abbott (NYSE:ABT), announced today an exclusive worldwide licensing agreement with Pierre Fabre SA to develop and commercialize h224G11, a pre-clinical monoclonal antibody identified at the Centre d'Immunologie Pierre Fabre (CIPF) in France and targeting the cMet receptor for the treatment of cancer.
BioMimetic Therapeutics, Inc. (Nasdaq: BMTI) announced today the European Patent Office (EPO) intends to grant patent application No. 05803356 titled “Platelet-Derived Growth Factor Compositions and Methods of Use Thereof”. The allowed claims cover compositions of platelet derived growth factor (PDGF) combined with matrix materials having defined characteristics, which cover the Company’s novel recombinant protein-device combination product candidates, including Augment™ Bone Graft and Augment™ Injectable Bone Graft, as well as GEMESIS™, which the Company previously sold to Luitpold Pharmaceuticals, Inc. The new patent, which expires in 2025, will provide protection against the marketing of similar or generic versions of Augment, Augment Injectable, and GEMESIS in Europe. This notice from the EPO enhances the Company’s existing, strong patent portfolio, which includes a similar patent in the United States effective through 2025.
Boston Scientific Corporation (NYSE: BSX) today announced the settlement of three patent disputes with Johnson & Johnson (J&J). The disputes date back to 2003 and cover Boston Scientific's Jang patent and J&J's Palmaz and Gray patents, all of which involve intellectual property in the cardiovascular arena. Boston Scientific will make a $1.725 billion payment to J&J in connection with the settlement. The first dispute involved a claim by J&J that Boston Scientific's Express®, TAXUS® Express® and Liberte® stents infringed its Palmaz and Gray patents.The second involved a claim by Boston Scientific that J&J's Cypher®, BX Velocity® and Genesis stents infringed its Jang patent.
Cephalon, Inc. (Nasdaq: CEPH) announced today that it has signed an agreement to acquire Mepha AG and its subsidiaries, a profitable, privately-held, Swiss-based pharmaceutical company. Mepha has specific expertise in innovative dosage formulations and markets both generic and branded generic products. The acquisition diversifies the company's business mix, doubles the size of its international business, and provides an attractive platform to launch current and future products in new, developed and emerging markets.Mepha manufactures and markets over 120 products in 50 countries and recognized sales of approximately CHF 400 million in 2009. With its exposure to high-growth international markets, and a track record of innovation, Mepha has achieved compound annual growth rates (CAGR) in sales of more than 13 percent over the last five years. In addition to its existing products, Mepha has a broad pipeline of approximately 50 chemical entities planned for launch over the next five years.According to the agreement, Cephalon will purchase Mepha AG for CHF 622.5 million, or an estimated $590 million USD, from the Merckle family-owned Mepha Holding AG, subject to adjustments upon closing. Cephalon expects that the acquisition will be accretive to adjusted earnings per share in 2010 and will update its 2010 guidance when it reports full year 2009 financial results on February 11, 2010. In the interim, the company withdraws its full year 2010 guidance issued on October 27, 2009.
"The addition of Mepha will transform our international business overnight, expanding our ability to serve global markets and reach patients in new territories for the first time," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon. "With this deal, we now serve all three types of pharmaceutical markets, proprietary branded, generic and branded generic. We believe this balance will increase the growth and stability of our business," added Baldino.
CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) announced the appointment of Nils Bergenhem, Ph.D., as its new Chief Scientific Officer, effective February 1, 2010. Dr. Bergenhem will succeed Fred Feldman, Ph.D., who is retiring after a 35 year career in research and drug development.
Depomed, Inc. (Nasdaq:DEPO) announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a U.S. patent application (No. 12/239,591) directed to pharmaceutical dosage forms that deliver the compound gabapentin via Depomed’s proprietary Acuform® gastric retentive drug delivery technology. Paul B. Simboli, Depomed’s senior director of Intellectual Property, commented that with the issuance of this additional patent, Depomed will hold six U.S. patents covering DM-1796, its product candidate for postherpetic neuralgia licensed to Solvay Pharmaceuticals, and holds or has sublicensed seven U.S. patents covering SeradaTM, its product candidate for menopausal hot flashes. The patents have expiration dates ranging from 2016 to 2024. The 21 newly allowed claims will expire in 2024. Carl A. Pelzel, Depomed’s president and chief executive officer, added, “This new patent further expands the patent portfolio around our extended release gabapentin formulation technology. There are significant near-term developments upcoming for both product candidates covered by this patent. We look forward to an NDA filing for DM-1796 for the treatment of postherpetic neuralgia later this quarter, and initiation of a Phase 3 trial for SeradaTM for the treatment of menopausal hot flashes early in the second quarter.”
Dyax Corp. (NASDAQ:DYAX), a developer of novel biotherapeutics for unmet medical needs, announced today that Gustav A Christensen, President and Chief Executive Officer of Dyax, will present at the 12th Annual BIO CEO & Investor Conference, being held February 8-9th at The Waldorf-Astoria Hotel in New York, NY.
Haemonetics Corporation (NYSE: HAE) and Global Med Technologies, Inc. (OTC BB: GLOB) today announced a definitive agreement under which Haemonetics will acquire Global Med for approximately $60 million in a cash tender offer.
As a global leader in blood management solutions, Haemonetics helps plasma fractionators, hospitals and blood collectors to improve clinical care and lower costs by optimizing the collection, processing, and use of scarce blood resources. Haemonetics' broad product offering includes blood collection and separation technologies, surgical blood salvage systems, and diagnostic products for enhanced blood management in the surgical setting. Haemonetics also markets information technology platforms and consulting services to help manage the blood supply chain and improve blood management practices.
Global Med is a healthcare information technology company which markets a breadth of software solutions and services that span the blood supply continuum, from blood collection to the hospital transfusion center to the patient care environment. Shares of Global shot up over 62% on the news.
InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) is scheduled to discuss the company's New Drug Application (NDA) for pirfenidone on March 9, 2010. Pirfenidone is InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
"There is an urgent unmet need for approved medicines for patients with IPF, a uniformly fatal disease that affects approximately 100,000 Americans, with more than 30,000 new cases diagnosed annually," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Despite the chronic, fatal nature of this disease, which has a higher mortality rate than that of colorectal cancer, breast cancer or prostate cancer, there are currently no approved medicines to treat IPF. We are looking forward to discussing with the Committee the data supporting the safety and efficacy of pirfenidone in IPF patients."
InterMune announced on January 4, 2010 that the FDA granted Priority Review designation for its NDA for pirfenidone for the treatment of IPF. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.
Shares of InterMune were up more than 5% on the day. More interesting was the options activity on Monday. Options for the March $17.50 and $20 strikes saw heavy activity as investors bet that the FDA panel will provide a positive review.
LecTec Corporation (OTCBB: LECT), announced today that it has begun a comprehensive R&D program to develop its proprietary hand sanitizer patch technology.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND), announced today that its President and Chief Executive Officer, John L. Higgins will be presenting fourth quarter 2009 financial results and provide general business updates at the BIO CEO and Investor Conference on Tuesday, February 9, 2010, at 9:00 a.m. Eastern time (6:00 a.m. Pacific).
Link Resources, Inc. (OTCBB: LNKR), today announced that the company has changed its corporate name to Bohai Pharmaceuticals Group, Inc. (“Bohai”).
MabCure, Inc. (OTCBB:MBCI), a biotechnology company using its proprietary technology to create highly specific monoclonal antibodies (MAbs) for the early detection of cancer, has been featured in a January 14, 2010 article published on GenomeWeb, the largest online news organization focused on advanced research tools in genomics, proteomics, and bioinformatics.
Mentor Capital, Inc.'s (Pink Sheets:MNTR), first funding tranche to extend its investment in its proprietary Cancer Immunotherapy Index closes today. Cash investment from 1,400 existing shareholders projects to be approximately 20% oversubscribed from target. Company management reservation to fund will be correspondingly reduced to remain within the $1.2 Million seed funding limit.
NeoStem, Inc.(Amex: NBS), As reported here earlier today on BioMedReports, NeoStem announced that it recently was advised that its Suzhou Erye Pharmaceutical subsidiary received approval from the State Food and Drug Administration (SFDA) in China to manufacture solvent crystallization sterile penicillin and freeze dried raw sterile penicillin at their new facility which provides 50% and 100% greater manufacturing capacity, respectively, than its existing facility. Historically, these two lines have accounted for approximately 20% of Erye's sales.
NeoStem's Chairman and CEO, Robin Smith, commented, "This also is the beginning of Erye's relocation of operations to the new facility, which will continue through 2011, as the new production lines are completed and receive cGMP certification. Once Erye has completed its relocation to the new facility, and its new production lines are fully operational, it will have substantially increased its capacity from the current plant with the goal of becoming among the largest antibiotic producers in Eastern China."
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT technology, today announced that the NASDAQ Listing Qualification Panel (the “Panel”) has determined that NexMed has evidenced compliance with the market value of listed securities requirement for continued listing on The NASDAQ Capital Market by evidencing a market capitalization in excess of $35 million for a minimum of ten consecutive trading days, in lieu of the $2.5 million in stockholder’s equity as required by the Panel’s decision dated December 17, 2009.
PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that it has submitted a White Paper in response to the Broad Agency Announcement (Solicitation Number: BAA-BARDA-09-34) issued by the Biomedical Advanced Research and Development Authority (BARDA) for the Advanced Research and Development of Chemical, Biological, Radiological and Nuclear Medical Countermeasures. In December 2009, this BAA was specially modified and extended to accommodate rPA-related submissions.
David P. Wright, President and Chief Executive Officer of PharmAthene, said, "In consultation with BARDA, today PharmAthene submitted a White Paper for advanced development of SparVax in response to the BAA. If BARDA finds our submission acceptable, a formal proposal will be requested. We believe that, if awarded, funding provided under this BAA, along with potential additional funding under our existing contract with BARDA, will be sufficient to advance SparVax to a stage where it will be eligible for consideration for a Project BioShield procurement contract."
Wright went on to say: "There has been widespread acknowledgement across the scientific community of the need for a next-generation anthrax vaccine that offers the potential for improved safety, convenience and cost-effectiveness. SparVax is the leading rPA-based vaccine and is well positioned to meet these requirements. We look forward to continuing our work with the government to develop the necessary medical countermeasure to successfully deter or quickly respond to a biologic attack and save American lives."
Rite Aid Corporation (NYSE: RAD), announced today that Chris Hall, formerly Senior Vice President, Strategic Business Development, has been named Senior Vice President, Pharmacy Business Development.
RXi Pharmaceuticals Corporation (Nasdaq:RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that the Company’s President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the 2010 BIO CEO & Investor Conference on Monday, February 8, 2010 at 11:30 a.m. ET.
Senomyx, Inc. (NASDAQ:SNMX), will release its financial results for the fourth quarter and fiscal year ending December 31, 2009 on Thursday, February 4, 2010 before the opening of the U.S. financial markets.
Stem Cell Therapy International, Inc. (OTCBB: SCII), announced that it has completed its merger with Histostem Ltd. of South Korea ("Histostem"), forming one of the first fully merged Pacific Rim stem cell companies and cord blood repositories with a U.S. entity.
SuperGen, Inc. (Nasdaq:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that James S.J. Manus, Ph.D., President and Chief Executive Officer, will present at Biotechnology Industry Organization’s CEO & Investor Conference on Monday, February 8th in New York.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that it has signed a definitive agreement to acquire Finnzymes, a well-recognized provider of integrated tools for molecular biology analysis, including reagents, instruments, consumables and kits.
Watson Pharmaceuticals, Inc. (NYSE: WPI) and HRA Pharma today announced an exclusive licensing agreement for Watson to become the commercial partner for ulipristal acetate (UPA), a selective progesterone receptor modulator in the U.S. UPA is a novel next-generation emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use that is approved and marketed by HRA Pharma in Europe as ellaOne® since October 2009. UPA is at the New Drug Application (NDA) stage in the U.S.
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