BioShares Biotechnology Clinical Trials (BBC): $19.21, -$0.76, +4.3% YTD

BioShares Biotechnology Products (BBP): $34.90, -$0.74, +6.6% YTD

 

 

MARKET COMMENTARY

 

With all eyes on Goldman Sachs and Citigroup earnings before the bell and a flurry of economic data releases, U.S. stock index futures pointed to a higher open. Consumer prices, industrial production, manufacturing output and NAHB housing market index are on the economic calendar. European shares were steady after a choppy start, while Asian markets closed mostly up. The prospect of rising U.S. production weighed on oil prices. Gold retreated from the previous day’s eight-week high as the dollar gained.

 

MARKET HIGHLIGHTS

 

Eli Lilly and CoLucid Pharmaceuticals announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. The transaction is expected to close by the end of the first quarter of 2017, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. While the financial charge will not be finalized until after completion of the acquisition, Lilly is expecting to recognize a financial charge of approximately $850 million (no tax benefit), or approximately $0.80 per share, as an acquired in-process research and development charge to earnings in the first quarter of 2017. The company’s reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company’s non-GAAP earnings per share guidance as a result of this transaction.

 

Bioblast Pharma announced results of a six-month open label Phase 2a study that also included an additional six-month follow-up period investigating trehalose in patients with Spinocerebellar Ataxia Type 3 (SCA3).  The objectives of the study were to establish safety and tolerability of two doses of trehalose as well as to assess the effect of the drug on reducing the rate of clinical decline in this progressively disabling disease.  The key findings of the study included:  Weekly trehalose infusions of both doses were generally safe and well tolerated. There were no changes in any safety laboratory parameters with treatment.  Patients remained stable over the 6-month period with no change on the Scale for Assessment and Rating of Ataxia (SARA) score – a well-accepted clinical tool for measuring the effect of the disease. The average score for all patients at baseline was 10.37 and after 26 weeks, the average score for these same patients was 10.25. The higher the score, the more symptomatic the patient.  Five patients received treatment for as long as 12 months and continued to remain stable on the SARA scale.

 

Paratek Pharmaceuticals announced today that it has completed enrollment in the pivotal Phase 3 clinical study evaluating omadacycline for the treatment of Community Acquired Bacterial Pneumonia (CABP). This study, which is designed to assess the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared with moxifloxacin in subjects with CABP, enrolled its first patient in November 2015. The company expects to report top-line data from this study in the second quarter of 2017.

 

Moberg Pharma AB announced that the New Skin® Spray SKU will be sold in 3,900 Walmart stores and in over 1,500 Walgreens stores. Opening orders expected to ship in mid-March.  New Skin® was aquired from Prestige Brands in July 2016. New Skin® is the #1 OTC liquid bandage brand in the U.S. It is an antiseptic which kills germs and dries rapidly to form a clear protective cover. New Skin® Spray will be sold in approximately 3,900 Walmart locations and 1,500 Walgreens locationsacross the U.S. New Skin® is already listed in several leading retailers including CVS, Rite Aid and Target.

 

Aeglea BioTherapeutics announced that it will present new clinical and research data in two presentations at the 2017 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting being held at the Phoenix Convention Center from March 21-25, 2017 in Phoenix, Arizona.

 

Kitov Pharmaceuticals Holdings will host a business update call on Monday, January 23rd at 8:30am Eastern Time to discuss the recent acquisition of a majority stake in TyrNovo, and to discuss the development plans for KIT-302, which is currently on-track for an NDA submission during the first quarter of 2017.

 

Zealand Pharma announced a $10 million milestone payment following Sanofi’s announcement of European Commission (EC) marketing authorization in Europe for Suliqua™, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. Suliqua™ is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

 

Neurocrine Biosciences announced the top-line results from the Company’s Phase II T-Forward study of INGREZZA (valbenazine), a highly-selective small molecule Vesicular Monoamine Transporter 2 (VMAT2) inhibitor, in adults with Tourette syndrome. While the study showed a significant improvement in overall symptoms of Tourette syndrome as evidenced by the Clinical Global Impression of Change (p=0.015), the pre-specified primary endpoint, the change-from-baseline in the Yale Global Tic Severity Scale (YGTSS) at Week 8 was not met (p=0.18). Adverse events were dose dependent and consistent with earlier clinical studies. Following Neurocrine’s announcement the Phase II study of Ingrezza in adult Tourette Syndrome showed improvement in overall symptoms based on CGI, but failed to meet the primary endpoint of change in YGTSS at week 8, Jefferies analyst Biren Amin decreased his price target to $56 from $61; Deutsche Bank analyst Andrew Peters decreased his price target to $62 from $65; Leerink analyst Paul Matteis decreased his price target to $65 from $70.

 

Apricus Biosciences announced that Mexico has granted Apricus’ commercialization partner, Ferring Pharmaceuticals, market approval for Vitaros, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction.

 

aTyr Pharma announced that its product candidate Resolaris was granted Fast Track designation by the FDA for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), making it the first known therapeutic candidate for the treatment of LGMD2B to receive the designation. In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.

 

Celsion announced that the USPTO has granted U.S Utility Patent No. 9,492,385 B2 — Temperature-Sensitive Liposomal Formulation, which is directly applicable to the method of treating cancer using the Company’s current ThermoDox formulation. The claims cover intravenous or direct (to the tumor) administration of the formulation followed by heating and extends coverage time over ThermoDox’s current parent patents. The Company also announced the issuance of Korean Patent No. 1652126 — Novel Thermosensitive Liposomes Containing Therapeutic Agents, which relates to composition claims directed to a thermally sensitive liposome that contains all of the components in the Company’s ThermoDox liposome as well as one additional lipid (DSPG).

 

The FDA announced that it has approved an ANDA for a generic version of Xyrem (sodium oxybate), a branded pharmaceutical product manufactured, marketed and sold by Jazz Pharmaceuticals. In connection with this approval, the FDA indicated that it has waived the requirement that Xyrem and generic sodium oxybate products utilize a single, shared system risk evaluation and mitigation strategy (“REMS”) and approved the generic version of Xyrem with a separate REMS. The Company was not involved in the development of the generic sodium oxybate REMS, which was not publicly available as of January 17, 2017. Based on publicly available information, the FDA “has determined that the generic sodium oxybate REMS has the same elements to assure safe use as the Xyrem REMS and operationalizes those elements in a comparable manner to the approved Xyrem REMS.” The Company will evaluate whether the FDA’s waiver of the requirement for a single, shared system REMS in connection with approval of the ANDA meets the conditions for such a waiver under applicable law and, to the extent that the Company determines that the waiver was not permissible under applicable law, intends to evaluate potential challenges to the FDA’s waiver decision.

 

Jazz Pharmaceuticals announced that the first patient has been enrolled in a Phase III clinical trial comparing the efficacy and safety of defibrotide versus best supportive care (BSC) in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or at very high risk of developing VOD. The defibrotide clinical trial will be conducted across approximately 100 medical centers in the U.S., Canada, Asia Pacific and countries in the EU.

 

ProMetic Life Sciences announced that its orally active lead drug candidate, PBI-4050, has been granted an orphan drug designation status for the treatment of Alström Syndrome by the European Commission.

 

Teva Pharmaceutical Industries announced the FDA approved VANTRELA ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva’s proprietary abuse deterrence technology. VANTRELA ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product’s approval is supported by a clinical program that evaluated the safety and efficacy of VANTRELA ER, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.

 

Daiichi Sankyo announced the initiation of a three-part open-label Phase I/II study in Japan with U3-1402, a novel HER3-targeting antibody drug conjugate, in patients with HER3-positive metastatic or unresectable breast cancer who are refractory or intolerant to standard treatment, or for whom no standard treatment is available.

 

Global Blood Therapeutics announced enrollment of the first patient in the HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study, a pivotal Phase III clinical trial of GBT440 in people with sickle cell disease (SCD). The HOPE Study will be conducted at leading SCD sites globally and is expected to enroll up to 400 adults and adolescents with SCD who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year.

 

ARCA biopharma announced that the 150th patient has been randomized into GENETIC-AF, a seamless Phase IIB/III clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF). The GENETIC-AF Data Safety Monitoring Board (DSMB) will conduct a Phase IIB interim efficacy, safety and futility analysis of evaluable data from at least 150 patients. The Company expects the outcome of this interim analysis in the third quarter of 2017.

 

Reuters reported that Allergan will pay a $15 million penalty and admit to wrongdoing, after U.S. regulators accused the company of failing to disclose merger talks with Actavis, the U.S. Securities and Exchange Commission said. In a statement, the SEC said that the disclosure failures occurred in the months after the company received a tender offer from Valeant Pharmaceuticals and co-bidders.

 

Immunomedics announced new data for sacituzumab govitecan (IMMU-132) during the company’s Investor R&D Day.

 

Boehringer Ingelheim announced that BI 695501, its adalimumab biosimilar candidate to Humira, has been accepted for regulatory review by the EMA and the FDA.

 

Galapagos announced the appointment of Dr. Walid Abi-Saab to the role of Chief Medical Officer, beginning on 1 March 2017.

 

Motif Bio announced that Robert Dickey IV has been appointed as Chief Financial Officer.

 

Summit Therapeutics announces the appointment of Dr. David Roblin as COO and President of Research and Development. In this new non-board role at Summit, Dr. Roblin will lead R& D and Commercial functions to support the development of the DMD and CDI programs. Dr. Roblin, who has been acting as a research and development adviser to Summit since 2014, will take up his new role on an interim basis in April 2017 with this becoming full-time in June 2017.

 

Merrimack Pharmaceuticals announced that Richard Peters, M.D., Ph.D., has been appointed as the Company’s President and CEO, effective February 6, 2017, at which time he will also be appointed to the Merrimack Board of Directors.

 

Actinium Pharmaceuticals announced that Dr. Mark Berger has been appointed Chief Medical Officer effective today.

 

 

ANALYST RECOMMENDATIONS

 

Following Alcobra’s announcement that top-line results from the Phase III MEASURE study showing that MDX missed the primary endpoint in adult ADHD, Jefferies analyst Biren Amin downgraded the stock to “hold” from “buy” and decreased his price target to $1.25 from $6; Cantor Fitzgerald analyst Mara Goldstein decreased her price target to $1 from $2.