BioShares Biotechnology Clinical Trials (BBC): $18.20, -$0.42, -37.3% YTD

BioShares Biotechnology Products (BBP): $32.76, -$0.49, +6.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock futures were little changed as investors readied for a three-day Christmas break, while the dollar weakened and gold inched higher. November data for new home sales and building permits are scheduled for release. Gains in Deutsche Bank and Credit Suisse, after the banks settled mortgage securities fraud suits with the United States helped push European shares higher. Oil slipped below $55 a barrel after Libya said it would increase production in the next three months.

 

 

MARKET HIGHLIGHTS

 

TiGenix NV announced that it has submitted its responses to the European Medicines Agency’s (EMA) Day 120 List of Questions for Cx601, its lead product candidate being developed for the treatment of complex perianal fistulas in patients with Crohn’s disease.  TiGenix expects to receive the EMA Day 180 List of Outstanding Issues in February 2017 and anticipates a decision from the EMA on Cx601 Marketing Approval during 2017 which, if approved, would trigger the payment by Takeda to TiGenix of €15 million.

 

Ohr Pharmaceutical reported results for its fourth quarter and fiscal year ended September 30, 2016.  For the year ended September 30, 2016, the Company reported a net loss of approximately $25.8 million, or ($0.82) per share, compared to a net loss of approximately $15.2 million, or ($0.54) per share in the same period of 2015.  At September 30, 2016, the Company had cash and cash equivalents of approximately $12.5 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.  On December 7, 2016, the Company closed on a public offering of common stock. Net proceeds from the offering were approximately $6.9 million, after deducting placement agent fees and estimated offering expenses payable but excluding the proceeds, if any, from the exercise of the Series A and Series B Warrants issued in the offering.

 

Santhera Pharmaceuticals announced that it has been informed that the UK`s Medicines and Healthcare Products Regulatory Agency (MHRA) designated Raxone® (idebenone) for the treatment of Duchenne muscular dystrophy (DMD) in patients with respiratory function decline not taking concomitant glucocorticoids as Promising Innovative Medicine (PIM) and as a suitable candidate for entry into Step II of the EAMS process.

 

Dipexium Pharmaceuticals and PLx Pharma announced that they have entered into a definitive agreement under which PLx Pharma will merge with a wholly-owned subsidiary of Dipexium in an all-stock transaction. Following closing, Dipexium will be renamed PLx Pharma Inc., and will operate under the leadership of the PLx management team with Michael Valentino serving as Executive Chairman of the company’s Board of Directors and Natasha Giordano serving as President and Chief Executive Officer.

 

Synergy Pharmaceuticals announced positive top-line results from the second of two pivotal Phase III clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,054 adult patients with irritable bowel syndrome with constipation (IBS-C).  Preliminary analysis of the data indicates that both plecanatide 3 mg and 6 mg doses met the study’s primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period. The most common adverse event was diarrhea which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups compared to 0.6% of placebo-treated patients.

 

Progenics Pharmaceuticals announced that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase III clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue.

 

Horizon Pharma announced that it has received a NOA from the USPTO for U.S. patent application number 13/610,580, entitled "Methods of Therapeutic Monitoring of Phenylacetic Acid Prodrugs" that covers Horizon’s U.S. approved medicine RAVICTI (glycerol phenylbutyrate) Oral Liquid. This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire on September 22, 2030.  After issuance, Horizon plans to list the U.S. patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

 

Biogen announced that the SEC has declared effective the Registration Statement on Form 10 filed by Bioverativ. Biogen expects to complete the separation of Bioverativ into an independent, global biotechnology company focused on hemophilia and other rare blood disorders on February 1, 2017.

 

Acceleron Pharma announced that the first patient has been treated in a Phase II clinical trial of ACE-083, the Company’s locally acting muscle agent, for the treatment of patients with facioscapulohumeral muscular dystrophy (FSHD).

 

Alcon, the global leader in eye care and a division of Novartis, has received approval from the FDA for its AcrySof IQ ReSTOR +3.0D Multifocal Toric Intraocular Lens (IOL). The new IOL is designed to address presbyopia and pre-existing corneal astigmatism at the time of cataract surgery in adult patients who desire good near, intermediate and distance vision with an increased potential for spectacle independence. The product is already commercially available in the European Union, Australia, Canada, and many countries in Central and South America and Asia.

 

Pfizer announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the U.S. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem) and Zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically addresses certain multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, one of the most significant unmet medical needs in bacterial infections treated with hospital anti-infectives.

 

Pluristem Therapeutics announced that following the recently adopted Chinese policy relating to outbound investments by Chinese companies, it has agreed with China-based Innovative Medical Management Co to extend the time of execution of the definitive agreements for Innovative Medical’s proposed investment of $30,000,000.  Pursuant to the existing term sheet, the parties intended to enter into definitive agreements no later than December 26, 2016. As a result of the recently adopted Chinese policy, the parties now plan to continue the discussions with respect to the definitive agreements until they have received further clarification about such policies, which is expected during the first half of 2017.

 

Benitec Biopharma announced that it has executed an exclusive, world-wide sublicensing agreement that will enable Benitec, in collaboration with NantWorks, to develop a clinical stage asset to treat Head and Neck Squamous Cell Carcinoma (‘HNSCC’) using a gene silencing approach that targets the Epidermal Growth Factor Receptor (EGFR). 

 

Sinovac Biotech responded to a recent report regarding the allegations raised in a research report by Geoinvesting. Sinovac’s Audit Committee has authorized the commencement of an internal investigation into the allegations made in the report. The Audit Committee has engaged Latham & Watkins as independent counsel to assist with the investigation. Pending the outcome of the investigation, to the knowledge of Sinovac, no legal proceedings or government inquiries have been made against the Company or its chief executive officer Mr. Yin, based on any claims described in the report. 

 

Aerie Pharmaceuticals reported that it has been notified by its third party manufacturing vendor that the manufacturing line related to Rhopressa in their Tampa, Florida facility will not be ready for pre-approval inspection by the FDA until the end of February 2017. In October 2016, the Rhopressa NDA was withdrawn due to the contract drug product manufacturer not being prepared for pre-approval inspection by the FDA. The contract drug product manufacturer had previously advised Aerie and the FDA that it expected to be prepared for FDA inspection in January 2017. The delay apparently does not result from any new findings, but rather additional time needed to complete validation of new equipment.

 

Helix BioPharma announced it has signed an exclusive out-license agreement with Xisle Pharma Ventures Trust for the Company’s late-stage, Biphasix technology platform, including the lead product candidate, interferon alpha. Xisle will be responsible for the continued clinical development and subsequent commercialization of the product for the treatment of HPV-induced, low-grade, cervical intraepithelial lesions. As part of its asset development strategy, Xisle has initiated collaboration with senior pharmaceutical executives at Altum Pharmaceuticals, who possess extensive regulatory, clinical, and product development expertise. Under the terms of the agreement, Xisle has paid an up-front fee and agreed to subsequent milestone payments as they advance the technology to registration and market approvals. Helix has retained marketing rights for certain territories. EVOLUTION Life Science Partners, a division of Gordian Investments acted as advisor to Helix BioPharma.

 

Neothetics announced the initiation of the Phase II proof of concept trial, LIPO-202-CL-31, for LIPO-202 for the reduction of submental subcutaneous fat.

 

Strongbridge Biopharma announced that it has entered into a definitive securities purchase agreement for a placement of its ordinary shares and warrants, which is expected to generate total gross proceeds to the Company of $35 million. The financing is being led by CAM Capital and Vivo Capital, with additional participation from Broadfin Capital, Boxer Capital of the Tavistock Group and HealthCap, as well as several new and existing institutional and individual investors. Stifel is acting as the lead placement agent, JMP Securities is acting as the lead co-placement agent, and H.C. Wainwright & Co., and Arctic Securities are acting as co-placement agents for the private placement. According to the terms of the definitive agreement, the Company will issue 14,000,000 ordinary shares to the investors at a price of $2.50 per ordinary share as well as warrants to purchase 7,000,000 shares. The warrants are exercisable at a price of $2.50 per share and expire five years from the date of issuance. The Company expects the closing of the private placement to occur on or about December 28, 2016, subject to satisfaction of customary closing conditions and the closing of the Company’s planned $40 million credit facility. Proceeds from the private placement will be used primarily to fund the Company’s separately announced acquisition of the U.S. rights to KEVEYIS (dichlorphenamide), from a subsidiary of Taro Pharmaceutical Industries, as well as the clinical development of the Company’s programs and other general corporate purposes.

 

Strongbridge Biopharma announced that the company has acquired the U.S. rights to KEVEYIS (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries. KEVEYIS was approved by the FDA in August 2015 to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. KEVEYIS has orphan drug exclusivity status in the U.S. through August 7, 2022. Under the terms of the purchase agreement, Strongbridge will provide Taro with upfront and deferred payments of $8.5 million in two installments; Taro is also eligible to receive additional future payments upon the achievement of certain sales unit milestones. Strongbridge expects to commercially launch KEVEYIS in the U.S. in April 2017. Taro has agreed to continue to manufacture KEVEYIS for Strongbridge under an exclusive supply agreement at least for the period of KEVEYIS orphan exclusivity, subject to certain commercial terms and conditions, including minimum supply purchases.

 

 

ANALYST RECOMMENDATIONS

 

Rodman & Renshaw analyst Raghuram Selvaraju increased his price target of Evoke to $2.50 from $2.00, citing favorable FDA guidance from a second pre-NDA meeting to discuss clinical data for includion in a 505(b) New Drug Application for its lead drug candidate, Gimoti.

 

Ladenburg Thalmann analyst Kevin DeGeeter decreased his price target of Mesoblast to $6.50 from $8.50, citing Mallinckrodt is not the optimal partner to execute the significant medical education that is likely to be required to gain wide clinical adoption for the first cell therapies to treat GVHD and CLBP.