Biotech Day in Review: Xoma Signs $230 Million Partnership with Takeda

Xoma (XOMA) extended its November 2006 partnership with Takeda to include more therapeutic antibodies.

The new program could be worth as much as $230 million plus royalties to Xoma, up from $100 million under the original agreement. Xoma has already earned $8 million in payments in the first four months of the original agreement. The increase came after exclusivity agreements expired between Xoma and an unnamed company. Xoma is using its phage display libraries and antibody optimization techniques to discover antibodies for targets that Takeda specifies. Xoma gained 18 cents to end at $3.20.

Avanir Pharma (AVNR) said the FDA will require another clinical trial for approval of Zenvia, a treatment for involuntary emotional expression disorder. Following an approvable letter from the FDA, Avanir proposed lower doses of Zenvia and Quinidine to the agency. Quinidine is given to reduce QTc intervals. The FDA asked for a new trial, one that shows the new lower dose regimen is effective and produces fewer side effects. Avanir projected two years as the length of time needed to conduct the trial. Avanir fell 17%, dropping 38 cents to end at $1.86.

Accentia Biopharmaceuticals (ABPI) acquired worldwide rights to Revimmune, a late-stage treatment for autoimmune diseases, from Johns Hopkins. Revimmune is an ultra-high intensity short course of an approved drug (cyclophosphamide) designed to reboot a patient’s immune system by eliminating peripheral immune cells, while leaving intact the stem cells in the bone marrow. Its initial target is MS. Revimmune will seek regulatory approval via the 505(b)(2) pathway, the pathway that is Accentia’s main focus.

According to researchers at Johns Hopkins, Revimmune produces a great improvement in most patients, and many see all disease activity eliminated. Follow-up has continued for up to 2 years. The license for Revimmune covers all 80 autoimmune diseases that have been identified, including multiple sclerosis, systemic lupus, juvenile diabetes mellitus, rheumatoid arthritis, Crohn's disease, myasthenia gravis, and scleroderma. Accentia also announced it placed $24.7 million in debentures that yielded $20 million in new cash. Accentia was off 17 cents at $3.66.

Nanogen (NGEN) received four patents for biomarkers related to diabetes and Alzheimer’s disease. Nanogen moved up 3 cents to $1.42.

Targeted Genetics (TGEN) reported its tgAAC09 vaccine for HIV is proving to be safe and well-tolerated in a Phase I test. The adeno-associated virus [AAV] vector delivers genes encoding HIV proteins. HIV-specific T-cell responses were observed in 20% of the participants who received the highest dose of tgAAC09 tested; however, no antibody responses were observed. Targeted Genetics will begin testing the vaccine at higher doses, with hopes they produce a more vigorous response. Targeted Genetics slipped 2 cents lower to $3.24.

Salix Pharma (SLXP) bought Pepcid Oral Suspension and Diuril Oral Suspension from Merck (MRK) for $55 million upfront and $6 million in sales-related milestones. Pepcid sold $20 million worth of product for ulcers and acid reflux; Diuril is used for edema. Because the oral formulation is used in hospitals, the products are useful for Salix, which is building a product line for hospitals. Salix fell 89 cents to $14.21.

Regeneron (REGN) presented data at a conference showing that its Interleukin-1 (IL-1) trap was effective and safe in patients with Cryopyrin-Associated Periodic Syndromes [CAPS]. The drug was given to adult patients who suffered from Familial Cold Autoinflammatory Syndrome [FCAS] or Muckle-Wells Syndrome [MWS]. Regeneron will file for approval of the drug in Q2. Regeneron was off 8 cents at $19.84.

Human Genome Sciences (HGSI) said that early data (week 12) from Phase IIb hepatitis trials show Albuferon to be as effective as interferon, but with fewer treatments and a better quality of life. The drug was administered with ribavirin to patients with genotype 1 hepatitis C; none of the patients had previously been given interferon. Human Genome gained 4 cents to end at $11.00.

Abbott (ABT) received FDA approval to market Humira to Crohn’s disease patients who do not respond to other treatments. Many patients are intolerant of Remicade (infliximab), a Johnson & Johnson (JNJ) drug, the only other approved biologic treatment for Crohn’s disease, while others develop resistance to it. The bulk of Humira’s revenues come from use for arthritis. Abbott was 78 cents higher at $54.62.

EnoCeutics [ENCX], a Canadian company developing hormone therapies for breast cancer and other endocrine-related disorders, filed its initial submission for an IPO, with the goal of raising up to $75 million.

After yesterday’s dramatic sell-off, biotech refused to either continue the downtrend or bounce off its lows. The Centient Biotech 200™ added on 1 point to end at 3930, while the S&P 500 was up .56% and Nasdaq gained .34%.

Disclosure: none.