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Sigma-Tau Pharmaceuticals of Gaithersburg, a wholly owned subsidiary of Sigma-Tau Group of Italy, is buying the specialty pharmaceutical business of Enzon Pharmaceuticals of Bridgewater, N.J., for up to $327 million.

The deal, which also includes a manufacturing plant in Indianapolis, comprises $300 million, plus up to $27 million based on success milestones. In addition, Enzon will also receive royalties of 5 percent to 10 percent on incremental net sales above a 2009 baseline amount from Enzon's four marketed specialty drugs through 2014.

Sigma-Tau will distribute the drugs — Enzon's only products on the market — in the U.S. They are Oncaspar, a leukemia treatment; Adagen, a treatment for severe combined immunodeficiency disease, also known the "Bubble Boy Disease;" DepoCyt, a meningitis drug; and Abelcet, for treating invasive fungal infections in patients with compromised immune systems.

The drugs complement Sigma-Tau's current line of drugs for rare diseases, said Marc Tewey, Sigma-Tau's vice president of commercial operations. The addition of the Enzor drugs is expected to push his company's annual sales to about $160 million, he said.

"We're dedicated to developing rare-disease medicines," Tewey said. "We will focus on diseases that affect only a few thousand people."

For example, the company is working with the National Institutes of Health to develop a product to treat cystinosis, which affects only about 300 Americans; the drops would help dissolve crystals in patients' eyes. Another product under development would help prevent necrotizing enterocolitis, which kills premature infants who weigh less than about 3 pounds.

The new Enzor drugs "fit into our strategic focus very well," Tewey said. For example, Oncaspar affects only about 4,000 Americans, two-thirds of whom are children. Only about 100 people worldwide, including 48 under treatment in the U.S., have the immune deficiency syndrome for which Adagen is indicated, he said.

Sigma-Tau's current line comprises three prescription drugs, including Carnitor, which is taken orally to treat a very rare metabolic disorder and was one of the first products to receive orphan drug status from the federal Food and Drug Administration, he said. Another prescription drug, Matulane, treats advanced Hodgkin's lymphoma.

Sigma-Tau also sells over-the-counter treatments for male infertility and bowel disorders.

Marketing drugs for such rare diseases typically involves lower promotional costs than for drugs for more common ailments, Tewey said. The company works closely with patient foundations and physicians, and helps to clear up insurance reimbursement issues.

The new Enzor drugs will mean a bigger work force for Sigma-Tau. The company now has about 30 employees at its Gaithersburg office, which is the Italian parent's North American headquarters, plus salespeople around the country. The company plans to bring some Enzor salespeople on board — "we're evaluating how many now," Tewey said.

The company does both commercial and research and development work in Gaithersburg, but "we're not a company with a lot of people in white coats," he said. Sigma-Tau conducts much of its research and development with clinical research organizations and universities.

Workers at the Indianapolis plant, where all four of the Enzor drugs are filled and finished, will also be added to Sigma-Tau's work force, he said. Close to 100 people work there.

The deal is contingent on the approval of Enzon's stockholders.

In other Maryland bioscience industry news:

Qiagen of the Netherlands, which provides sample and assay technologies worldwide, plans to acquire privately held SABiosciences Corp. in Frederick for $90 million in cash, according to a Qiagen statement.

In an e-mail, Qiagen spokesman Przemek Jedrysik said that "overall, we ... expect to further grow the existing Frederick site in the near future." SABiosciences, with about 100 employees, provides gene array products and other research tools to the bioscience industry.

Qiagen's North American headquarters are in Germantown. In 2007, Qiagen acquired Digene of Gaithersburg for $1.6 billion.

BioMarker Strategies has won a Fast-Track Small Business Innovation Research contract worth up to $2.3 million from the National Cancer Institute to develop its live-tumor-cell testing system, SnapPath.

The Baltimore company is developing the system to help oncologists determine the most effective drug treatment for their cancer patients.

BioMarker is to receive an initial award of $254,000 and may receive an additional $2 million when the first phase of work is completed, according to company information.

"We are gratified by this award from the NCI to support the development of our SnapPath technology and plan to use these funds to expedite production of a prototype of our live-tumor-cell testing system," said CEO K‰ren Olson in a statement.

Nabi Biopharmaceuticals has closed its previously announced sale of PentaStaph to GlaxoSmithKline for up to $47.5 million, comprising an initial $21.5 million, plus up to $26 million in milestone payments expected over the next 16 months.

"The completion of this transaction marks another significant step in our strategic alternatives process," said Nabi CEO Raafat Fahim in a statement.

Nabi also has begun the first of two pivotal phase 3 studies of NicVax, its vaccine to treat nicotine addiction and prevent smoking relapse. The study is being funded partly with a $10 million grant from National Institute on Drug Abuse.

"This is a significant step for Nabi, our shareholders and the millions of smokers around the world who want to quit smoking," Fahim said in a statement. "The initiation of the phase 3 study solidifies our leadership position as the most advanced smoking cessation pipeline vaccine. We are encouraged by the increased interest in this program while we continue to pursue a strategic partnership for the continued development and commercialization of NicVax."

In other company news, Nabi reported that Biotest Pharmaceuticals has withdrawn its claim and agreed to release the remaining $5.7 million of its original $56 million indemnification claim made on March 31 against Nabi. Earlier, Biotest withdrew a $50.4 million indemnification claim. The withdrawal settles the last of Biotest's outstanding indemnification claims made by Biotest in March relating to assets transferred to Biotest as part of Nabi's sale of its biologics business unit to Biotest in December 2007, according to a company statement.

TNFerade, GenVec's candidate for treating pancreatic cancer, has been granted orphan drug designation by the FDA, the Gaithersburg biotech announced.

The designation is granted to treatments that may provide a significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer Americans annually, the company said. The designation can mean financial and regulatory incentives, including study design assistance, waiver of FDA user fees, tax credits and up to seven years of market exclusivity upon marketing approval. The FDA has granted such status to more than 1,700 treatments, with more than 300 achieving marketing approval, according to the agency.

"Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits," CEO Paul Fischer said in a statement.

Privately held biotech Neuronascent of Clarksville, which is developing neurogenic small-molecule drugs to treat depression, Alzheimer's and Parkinson's diseases, and other neurodegenerative diseases, announced a discovery agreement with ChemRar Pharma, a Russian biotech startup, which is developing cancer treatments.

Neuronascent will screen certain ChemRar proprietary developmental pathway inhibitors, using its proprietary drug discovery platform for neurogenesis and neuroprotection, according to a company statement. Financial terms were not disclosed.

Gaithersburg biotech VIRxSYS has raised $9.8 million of a $40 million mixed offering, according to its filing with the Securities and Exchange Commission.

The privately held company's lead program, now in phase 2 human clinical trials, is an anti-HIV therapy. The company also has projects in HIV vaccine, cardiovascular diseases, hemophilia A, induced pluripotent stem cell generation and second-generation antibody development, according to its Web site.

Cyto Pulse Sciences of Glen Burnie said it received approval from Swedish regulatory authorities to begin a phase 1/2 safety study of its electric field-based, intradermal DNA vaccine delivery systems in patients with colorectal cancer.

"We expect this type of gene delivery to be more immunogenic than previous deliveries," said Britta Wahren, professor in clinical virology at Karolinska Institutet and the Swedish Institute for Infectious Disease Control, in a statement. "When competing against cancer, one way is to redirect the patient's immune response to eradicate many or all tumor cells in the body."

Micromet of Bethesda agreed to buy out MedImmune's remaining rights to blinatumomab in North America, and to terminate their 2003 collaboration agreement under which the Gaithersburg biotech was granted the right to develop and commercialize blinatumomab in North America.

Micromet now controls the global rights to develop and commercialize blinatumomab, a novel therapeutic antibody that activates a patient's T cells to seek out and destroy lymphoma and leukemia cells.

Micromet is to make undisclosed upfront, milestone and royalty payments to MedImmune related to the development and North American sales of the product, according to a Micromet statement.

"The advancement of blinatumomab in the clinic is the top priority for Micromet," said Micromet CEO Christian Itin in the statement. "With complete control over global development and commercialization of blinatumomab, Micromet can develop an integrated clinical and regulatory strategy across multiple commercial territories, starting with the first pivotal study that we expect to initiate in 2010."

Micromet recently announced that blinatumomab had achieved its primary endpoint in an ongoing phase 2 clinical trial.

Archexin, a cancer drug being developed by Rexahn Pharmaceuticals, was recently named one of the 10 most promising oncology products in development that is available for strategic partnering.

The selection was by an independent committee assembled by Windhover Information, which provides business information products and services to senior executives in the pharmaceutical, biotechnology and medical device industries. The panel evaluated hundreds of compounds in development for treating cancer, according to information from the Rockville biotech.

"Archexin has the potential to become an important therapeutic for the treatment of pancreatic cancer, which has a mortality rate of almost 100 percent," said Chairman and CEO Chang Ahn in a statement. "We look forward to 2010 when we expect preliminary human data from our ongoing phase 2 trials."

Novavax recently reported positive data for its trivalent seasonal flu vaccine candidate in a second phase 2 study. The Rockville biotech said the virus-like particle vaccine induced "robust" antibody responses against all vaccine strains and a drifted strain. The study involved 241 subjects.

"We are pleased with the results of this study, which support continued development of novel [virus-like particle] vaccines against influenza and moving forward with our head-to-head study in the elderly population this fall," said CEO Rahul Singhvi in a statement.

The company has also launched a phase 2a clinical study of the vaccine candidate in healthy adults 60 or older. The study will evaluate the safety, tolerability and immunogenicity of two different doses of the vaccine compared with that of a commercially available trivalent inactivated vaccine.

Global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013, according to company information.