• Applied Biosystems, of Carlsbad, Calif., a division of Life Technologies Corp,, and the Translational Genomics Research Institute have formed an alliance to accelerate research into complex diseases and medical conditions. A team of scientists from TGen and Applied Biosystems will employ the sequence DNA from thousands of patients with a variety of diseases. The goal is to translate scientific discoveries at the genetic level into knowledge about the underlying causes of disease that ultimately may be used to create cutting-edge tools for use in clinical diagnosis.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said the Scottish Medicines Consortium accepted Toctino (alitretinoin) for use in adults with severe chronic hand eczema that is unresponsive to topical corticosteroids. The product previously gained approval in Denmark, Germany, the UK, Finland and France, and has been recommended for approval in six additional European Union member states.

• BVF Acquisition LLC, of New York, an affiliate of Biotechnology Value Fund LP, said it extended its tender offer for all the outstanding shares of Alameda, Calif.-based Avigen Inc. for $1 each until April 3. It previously extended the offer from Feb. 23 to March 6. As of March 6, 2,854,626 shares had been tendered. Avigen's board previously had rejected BVF's offer, while San Diego-based MediciNova Inc. also made an offer for the biotech firm. (See BioWorld Today, Jan. 26, 2009, and Feb. 9, 2009.)

• Cell Therapeutics Inc., of Seattle, said it received notice from Nasdaq that its common stock will continue to be listed, subject to the company's demonstrating compliance with all applicable standards by April 6. Specifically, the firm must attain the $35 million market value of listed securities, or one of its alternative requirements.

• Cel-Sci Corp., of Vienna, Va., has granted Byron Biopharma an exclusive license to market and distribute the company's cancer drug Multikine in the Republic of South Africa. Byron will purchase $750,000 worth of stock from Cel-Sci and will make a payment of $125,000 in 12 months. Byron also will be responsible for registering the product in South Africa. Once Multikine has been approved, Cel-Sci will be responsible for manufacturing the product, while Byron will be responsible for sales in the territory. Revenues will be split 50-50 between the two firms.

• Exact Sciences Corp., of Marlborough, Mass., said it received notice from Nasdaq that it was no longer in compliance with the marketplace rule calling for a minimum of $35 million in market value or stockholders' equity of at least $2.5 million. The company has through June 4 to regain compliance or face delisting of its stock.

• Genaera Corp., of Plymouth Meeting, Pa., reported that an independent accounting firm listed the company as a "going concern" in an unqualified audit opinion of the company's annual financial report. The company has about $8.1 million in cash and equivalents as of Dec. 31, 2008.

• Genavia Therapeutics Ltd., of Auckland, New Zealand, has licensed technology from Origen Therapeutics Inc., of Emeryville, California, for production of therapeutic proteins in chicken eggs. The patent-protected technology has been shown capable of producing in egg whites therapeutic proteins. Financial details were not disclosed. Genavia initially will apply the avian transgenic technology to produce human Factor VIII, an essential clotting factor that is missing in the blood of hemophilia A patients.

• Genta Inc., of Berkeley Heights, N.J., said the FDA Center for Drug Evaluation and Research (CDER) has turned down the company's appeal of the rejection of Genasense (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia. In a decision issued in response to an appeal filed by Genta in December 2008, CDER concluded that new information in the firms amended new drug application was insufficient, and the agency has recommended conducting a confirmatory clinical trial. Shares of Genta (OTC BB:GNTA) dropped 30 percent to close at 1 cent.

• Gilead Sciences Inc., of Foster City, Calif., said the FDA issued a warning letter about alleged false or misleading statements made by a company representative about the drug Letairis, a treatment for pulmonary arterial hypertension. According to the FDA, during a Pulmonary Hypertension Association conference in June 2008, a Gilead representative stated that the risk management plan for Letairis "is only there because of the class . . . this is not that big of a deal." The unnamed company representative went on to say that Letairis has a lower incidence of liver enzyme elevations compared to Tracleer. The FDA said those statements minimize the serious risks associated with Letairis.

• GTC Biotherapeutics Inc., of Framingham, Mass., has received a $1 million milestone payment from Ovation Pharmaceuticals Inc., of Deerfield, Ill., the commercialization and development partner for ATryn (antithrombin [recombinant]) in the U.S. The milestone payment reflects the recommendation for approval by the blood products advisory committee meeting in January.

• IDM Pharma Inc., of Irvine, Calif., said the European Commission granted a centralized marketing authorization application for Mepact (mifamurtide) in patients with nonmetastatic, resectable osteosarcoma. That allows the drug to be marketed in the 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Mepact was granted orphan status in 2004 and is entitled to 10 years of marketing exclusivity in Europe. IDM continues to work with U.S. regulators to address issues raised in the 2007 nonapprovable letter. (See BioWorld Today, Aug. 28, 2007.)

• Isolagen Inc., of Exton, Pa., said it submitted a biologics license application for Isolagen Therapy, a cellular treatment of wrinkles nanolabial folds. The BLA was based on data from Phase III trials conducted under a special protocol assessment.

• MannKind Corp., of Valencia, Calif., has entered into agreements with Pfizer Inc., of New York, to purchase Pfizer's insulin facility at Industriepark Hoechst, Frankfurt am Main, Germany and assets related to the production of bulk insulin, including the real property rights, the production equipment, a quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery. The aggregate purchase price is $33 million, subject to certain adjustments. At MannKind's option, up to $30 million of the company's common stock may be issued to Pfizer at closing and applied toward the full purchase price. Upon the closing of this transaction, MannKind said it intends to retain more than half of the current work force and plans to operate the facility at a production level commensurate with the company's present needs for recombinant human insulin.

• Mymetics Corp., of Nyon, Switzerland, has signed a share purchase agreement to acquire 100 percent of Bestewil Holding BV, parent company of Virosome Biologicals BV, from Norwood Immunology Ltd. for cash and considerations. The purchase price of €7.5 million (US$9.4 million) includes cash of €5 million, a secured 36 month 5 percent convertible and redeemable note of €2.5 million, as well as options with a value of approximately $9.6 million. Conversion will be at the lesser of 80 cents or the issue price of the shares of common stock issued after the closing date for the purpose of raising the necessary funds to repay the bridge loan. The deal also includes a payment of up to €2.8 million in cash in the event of a license agreement being signed with a third party to access; Bestewil intellectual property and know-how in the field of respiratory syncytial virus; a payment of up to €3 million in cash should Solvay Pharmaceuticals BV commence a Phase III trial for its intranasal influenza vaccine; a payment of 50 percent of Mymetics net royalties received from a RSV license, payable in cash to Norwood; and a 25 percent share of any net amounts received by Mymetics from a third-party herpes simplex virus license based upon Bestewil intellectual property payable in cash.

• Neuralstem Inc., of Rockville, Md., said a paper published in the current online edition of the Journal of Comparative Neurology reported that transplanted human neural stem cells (hNSCs) it developed made synaptic contacts with the motor neurons of rats with ALS-like symptoms. That constitutes evidence that the transplanted cells integrated into the nervous system of the host, the company said. The rats had a genetic mutation called SOD-1 G93A, which gives them a disease similar to ALS in humans. Earlier work with that ALS model showed that the stem cells delayed onset of the disease and played a neuroprotective role, but the new evidence showed the cells can become an integral part of the rat nervous system that controls the muscles.

• Northfield Laboratories Inc., of Evanston, Ill., has eliminated 13 positions at its manufacturing facility in Mount Prospect, Ill., and has reduced hours for remaining staff to conserve cash. In addition, Northfield advised state and local officials that unless additional funding is obtained, the company plans to close the plant under the Illinois law, which may result in the termination of employees at its main office and plant facilities in 60 days, or approximately May 5. At the end of the second fiscal quarter on Nov. 30, 2008, Northfield had $10.1 million in cash and marketable securities. Based on the measures taken, Northfield said it will have sufficient cash to continue operations until April 30. Northfield has a target FDA review date of April 30 for its biologics license application for its human hemoglobin-based oxygen carrier, PolyHeme.

• Novozymes Biopharma UK Ltd., of Nottingham, UK, said it signed a license agreement with GE Healthcare Life Sciences, of Piscataway, N.J., enabling Novozymes to produce and deliver native, animal-free protein A using GE technology. Terms were not disclosed.

• Pharmos Corp., of Iselin, N.J., received notice from Nasdaq that it is no longer in compliance with the minimum $2.5 million stockholders' equity requirement for continued listing. The company said it does not intend to appeal that determination and anticipates that its shares will be moved to the Over-the-Counter Bulletin Board or another market.

• Pico Pharmaceuticals Inc., of San Diego, reported that Pico's co-founder and colleagues from the Albert Einstein College of Medicine published experiments in the journal Nature Chemical Biology in support of the idea that inhibiting the enzyme 5'-methylthioadenosine nucleosidase or MTAN can disrupt quorum-sensing pathways in bacterial pathogenesis, and so might be a useful anti-infective strategy. Pico's lead compounds target the MTAN pathway.

• Sunesis Pharmaceuticals Inc., of South San Francisco, Calif., has sold to SARcode Corp., of San Francisco, its intellectual property and other assets in its LFA-1 inhibitor program previously licensed to SARcode for a total cash consideration of $2 million. As a result, Sunesis and SARcode have terminated an earlier license agreement relating to that program, and Sunesis will forego future potential milestone payments and royalties under the license agreement. Under that agreement, Sunesis has received milestone payments in the form of cash or convertible notes for the selection of SAR1118 as a development candidate, and for the initiation of a Phase I trial of SAR1118. Sunesis still holds a series of secured convertible notes issued by SARcode having a total principal value of $1 million.

• TetraLogic Pharmaceuticals, of Malvern, Pa., has licensed exclusive rights to necrostatin compounds and related drug discovery technology from Harvard Medical School. Necrostatins are small-molecule compounds that block a programmed cell death process called necroptosis. TetraLogic intends to commence human clinical studies of necrostatins during mid-2010.

• Watson Pharmaceuticals Inc., of Corona, Calif., said it has reached a settlement with Elan Corp. plc, of Dublin, Ireland, on patent litigation related to Watson's generic version of Naprelan (naproxen sodium) tablets. Under the terms of the agreement, Watson will pay Elan $18 million in full settlement of all disputes related to Watson's development, manufacturing, marketing and sale of its naproxen sodium product. Watson also has agreed not to market or sell its product until the expiration or final finding of invalidity or unenforceability of the patent.