Soligenix Announces FDA Clearance of Phase 3 Clinical Protocol of SGX301 in Cutaneous T-Cell Lymphoma

Pivotal Phase 3 Clinical Trial Targeted to Begin in First Half of 2015

PRINCETON, N.J., Sept. 17, 2014 -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal, Phase 3 clinical trial evaluating its product SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).

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Tokai Pharmaceuticals Announces Pricing of Initial Public Offering

CAMBRIDGE, Mass.-- Tokai Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases, today announced the pricing of its initial public offering of 6,480,000 shares of common stock at a public offering price of $15.00 per share, before underwriting discounts and commissions. All of the shares in the offering are being sold by Tokai. In addition, Tokai has granted the underwriters a 30-day option to purchase from the company, at the public offering price, less underwriting discounts and commissions, up to an additional 972,000 shares of common stock. Tokai’s common stock is expected to begin trading on The NASDAQ Global Market on Wednesday, September 17, 2014 under the ticker symbol “TKAI.”

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CTI BioPharma And Servier Announce Exclusive License And Collaboration Agreement To Develop And Commercialize PIXUVRI®

- Total Deal Valued at up to Approximately $133.5 Million; Approximately $18.1 million Upfront -
- CTI Retains 100% Commercialization Rights to PIXUVRI in U.S. and Certain E.U. Territories -

SEATTLE, Sept. 17, 2014 -- CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) and Servier today jointly announced that they have entered into an exclusive license and collaboration agreement to develop and commercialize PIXUVRI® (pixantrone) in a transaction valued at up to €103.0 million (approximately $133.5 million) if all milestones are achieved. Under the agreement, CTI retains full commercialization rights for PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United Kingdom and the U.S., with Servier having exclusive rights to commercialize PIXUVRI in all other countries.

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Auxilium Responds To Unsolicited Proposal From Endo International

Adopts One Year Stockholder Rights Plan

CHESTERBROOK, Pa., Sept. 17, 2014 -- Auxilium Pharmaceuticals, Inc. (AUXL), a specialty biopharmaceutical company, today confirmed that Auxilium has received an unsolicited, non-binding proposal from Endo International plc (ENDP) to acquire all of the outstanding shares of Auxilium common stock at a price of $28.10 per share in cash and Endo stock, subject to due diligence, financing and other conditions. A copy of the unsolicited, non-binding proposal that Auxilium received from Endo on Friday evening is reproduced below. Click here to view the letter.

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Avanir Pharmaceuticals Announces Positive Phase II Trial Results for AVP-923 in Treatment of Agitation in Patients with Alzheimer's Disease

- Significantly Improved Agitation in 220-Patient 10-week Study -
- Company Plans to Meet with FDA to Discuss Initiation of Pivotal Development Program -
- Data to be Presented at the American Neurological Association Meeting in October -

ALISO VIEJO, Calif., Sept. 15, 2014 -- Avanir Pharmaceuticals, Inc. (AVNR) today announced positive results from its phase II clinical trial evaluating the safety and efficacy of AVP-923 for the treatment of agitation in patients with Alzheimer's disease. Treatment with AVP-923 was associated with significantly reduced agitation as measured by the primary endpoint, the agitation/aggression domain score of the neuropsychiatric inventory (NPI) compared to placebo (p=0.00008).  The reduction in agitation was observed in both stage 1 (p=0.0002) and stage 2 (p=0.021) of the Sequential Parallel Comparison study design.

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