BioShares Biotechnology Clinical Trials (BBC): $19.15, -$0.15, +4.0% YTD

BioShares Biotechnology Products (BBP): $34.39, -$0.17, +5.0% YTD

 

 

MARKET COMMENTARY

 

Tracking weakness in European shares, U.S. stock index futures were down and the dollar hit a six-week low after President Donald Trump’s protectionist speech pushed investors into safe-haven assets. Asian markets closed mostly higher, though Japan’s Nikkei index and shares in Australia dropped after Trump’s administration also declared its intention to withdraw from the Trans-Pacific Partnership, a 12-nation trade pact that Japan and Australia have signed. Oil fell as signs of U.S. output rise overshadowed OPEC-led cuts, while gold touched its highest level in two months.

 

 

MARKET HIGHLIGHTS

 

Biotest’s US subsidiary, Biotest Pharmaceuticals, has entered into a definitive agreement with ADMA Biologics to sell certain assets of the US therapy business. Included in the assets to be transferred at closing are BPC’s plasma fractionation facility, its commercial products, contract manufacturing agreements as well as BPC’s Boca Raton, Florida headquarters and real properties.  Upon closing of this transaction, Biotest will receive equity interest in ADMA’s issued and outstanding capital stock in the form of 50% minus one share representing 25% of the voting rights.

 

Kamada announced today the positive Scientific Advice response from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) focused on the Company’s development program in Europe for Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (aGvHD) with lower gastrointestinal involvement.  The response from the CHMP included important guidance related to the design of the Company’s planned Phase 2/3 European study and the regulatory pathway for approval based on conducting such a study.

 

Immune Pharmaceuticals announced today that it has entered an exclusive sub-license agreement with SATT Sud-Est, a French Technology Transfer Office, to develop, use, manufacture and commercialize mono- and bispecific antibodies targeting components of the tumor microenvironment and angiogenic factors. The research program will be carried out under the responsibility of Inserm, CNRS (National Center for Scientific Research), UCA (University Cote d’Azur), CSM (Scientific Center of Monaco), and Immune Pharmaceuticals.

 

Marinus Pharmaceuticals announced positive preliminary data from the initial CDKL5 patients enrolled in its ongoing Phase II open-label study evaluating its CNS-selective GABAA modulator, ganaxolone, as a treatment for orphan, genetic disorders. CDKL5 is a severe, rare genetic disorder that results in early-onset, difficult-to-control seizures, and neuro-developmental impairment. Enrollment is continuing in the study with top-line data expected in mid-2017.

 

Aptose Biosciences announced it will prioritize its resources toward the development of CG’806, an oral preclinical compound being developed for patients with FLT3-driven acute myeloid leukemia (AML) and certain BTK-driven B-cell malignancies. Aptose will temporarily delay clinical activities with APTO-253, a phase 1 stage compound for AML, in order to elucidate the cause of recent manufacturing setbacks related to the intravenous formulation of APTO-253, with the intention of restoring the molecule to a state supporting clinical development and partnering.

 

Merck announced it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb and Ono Pharmaceutical, resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as KEYTRUDA (pembrolizumab).  Under the settlement and license agreement, the company will make a one-time payment of $625 million to Bristol-Myers Squibb and provide royalties on the worldwide sales of KEYTRUDA for a non-exclusive license to market KEYTRUDA in any market in which it is approved. For global net sales of KEYTRUDA, the company will pay Bristol-Myers Squibb royalties as follows: 6.5 percent of net sales occurring from Jan. 1, 2017 through and including Dec. 31, 2023; and 2.5 percent of net sales occurring Jan. 1, 2024 through and including Dec. 31, 2026. The parties also agreed to dismiss all claims in the relevant legal proceedings.

 

Merck KGaA announced it has entered into a collaboration and licensing agreement with Domain Therapeutics, to explore the potential of adenosine inhibition in the development of novel immuno-oncology agents. This collaboration strengthens our combination strategy in immuno-oncology, and underscores Merck KGaA, Darmstadt, Germany’s science-driven approach to discovering and developing novel compounds through both internal capabilities and external collaborations.

 

Enteris BioPharma announced the initiation of a feasibility study agreement with Sanofi to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence, to develop an oral formulation of one of Sanofi’s preclinical stage peptides.

 

Ocular Therapeutix announced that it has resubmitted a NDA to the FDA for DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of ocular pain occurring after ophthalmic surgery. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.

 

Elite Pharmaceuticals reported the Company received official minutes from its December 21, 2016 end-of-review meeting with the FDA for the NDA for SequestOx (oxycodone hydrochloride and sequestered naltrexone hydrochloride). The meeting minutes support a plan to address the issues cited by the FDA in the July 14(th) Complete Response Letter by modifying the SequestOx formulation. Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOx application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.

 

Lannett announced that the company voluntarily made a $75 million payment against its existing revolving credit facility.

 

Theravance Biopharma reported new interim data from the Company’s ongoing Telavancin Observational Use Registry (TOUR) study in an oral presentation at the Society of Critical Care Medicine’s (SCCM) 46th Critical Care Congress. TOUR is designed to assess how VIBATIV (telavancin) is being used by healthcare practitioners to treat patients in real-world clinical settings. The presented findings, which focused on a subset of registry patients with diagnoses of bacteremia or infective endocarditis (IE) (n=45), demonstrated positive clinical responses in 64.4% of patients, with 6.7% of patients failing treatment and 28.9% considered non-evaluable. Positive clinical response was defined as cure or improvement leading to step-down oral therapy. The SCCM 46(th) Critical Care Congress is being held in Honolulu, HI on January 20-25, 2017.

 

Macrocure announced that the previously reported merger transaction with a wholly-owned subsidiary of Leap Therapeutics has been completed. Pursuant to the transaction, shareholders of Macrocure will receive the merger consideration of 0.1815 shares of common stock of Leap per ordinary share of Macrocure cancelled, plus cash in lieu of a fractional share of Leap common stock (based on a value of $9.90 per share of Leap common stock). The trading of Macrocure’s ordinary shares on the NASDAQ Global Market has ceased, and the trading of Leap common stock on NASDAQ (under the trading symbol "LPTX") is expected to begin tomorrow (January 24, 2017).

 

Eyegate Pharmaceuticals, announced that it has been granted Canadian Patent No. 2,716,390 by the Canadian Intellectual Property Office. The patent, titled "ENHANCED DELIVERY OF A THERAPEUTIC TO OCULAR TISSUES THROUGH IONTOPHORESIS," covers an aqueous dexamethasone formulation comprising dexamethasone phosphate and the use of the formulation for delivering dexamethasone phosphate to ocular tissue via iontophoresis. The Company holds similar patents in the United States, Mexico, Australia and Israel, with applications pending in Europe and Brazil.

 

Novelion Therapeutics announced that the EMA has accepted for review the MAA for metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL). The MAA was filed in December 2016. An opinion from the CHMP is expected in December of 2017, and decision is expected in the first quarter of 2018.

 

Ritter Pharmaceuticals announced that it is collaborating with the newly-established Food for Health Center at the University of Nebraska ("NU") to study the role of the microbiome and RP-G28 in metabolic syndrome.

 

NeuroVive Pharmaceutical announced that NeuroVive has signed a preclinical collaboration agreement with the Children’s Hospital of Philadelphia (CHOP) and Marni J. Falk, M.D., a US key opinion leader in the mitochondrial medicine field.

 

Laboratoris Sanifit announced that the first patient has been enrolled in the Phase IIb "CaLIPSO Study" clinical trial of lead candidate, SNF472, for the treatment of cardiovascular calcification (CVC) in end-stage-renal-disease (ESRD) patients on haemodialysis (HD).

 

PixarBio announced that it will stay focused on the NeuroRelease Pain platform and continue to drive non-opiate non addictive morphine replacement to market with FDA approval expected between the end of 2018 and early 2019. The company has withdrawn their offer for InVivo Therapeutics for reasons related to management credibility and competence, corporate governance and IP control.

 

Eagle Pharmaceuticals announced that it has completed the submission of its 505(b)(2) NDA for Ryanodex for the treatment of exertional heat stroke (EHS) to the FDA. There is no currently approved drug treatment for EHS. Due to the life-threatening nature of EHS and the unmet need for an effective drug treatment for EHS, Eagle has requested Priority Review of this NDA for Ryanodex. If granted, as anticipated, a PDUFA date for a decision on the NDA would be July 2017; otherwise the Company anticipates approval later in 2017.

 

Sunesis Pharmaceuticals announced clinical and regulatory updates to its two lead programs, SNS-062, a second-generation reversible and non-covalent BTK inhibitor, and vosaroxin, an anti-cancer quinolone derivative currently under review for marketing authorization as a treatment for relapsed/refractory acute myeloid leukemia (AML) in Europe. For SNS-062, the company announced that its IND application with the FDA is now active, supporting the initiation of a Phase IB/II study to assess the candidate’s safety and efficacy in patients with advanced B-cell malignancies after prior ibrutinib exposure, including in patients with C481S mutations. The company also announced continued progress with its MAA for vosaroxin. Sunesis recently received the Day 180 List of Outstanding Issues, issued by the CHMP as part of the centralized review process.

 

Resverlogix announced preliminary results from the New Zealand based Phase II trial with severe kidney (renal) impaired patients. The data showed remarkable results in reducing inflamed protein biomarkers in patients with severe kidney impairment versus healthy control patients. It is believed that this is the first time in medical history that a direct connection of this type can be made between epigenetic regulation and its potential for positive disease impact. Both the healthy group and the severely impaired kidney group received equal amounts of apabetalone.

 

MOLOGEN AG announced first combination data of its TLR9 agonist lefitolimod with checkpoint inhibitors. The data show that lefitolimod, a so-called Immune Surveillance Reactivator (ISR), can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models. The beneficial effect of the combination of lefitolimod with anti-PD-1 compared to each monotherapeutic approach was confirmed in in-vitro experiments. All these results constitute a first preclinical confirmation of the combination approach of lefitolimod with checkpoint inhibitors in the treatment of cancer.

 

FibroGen announced that updated results from an ongoing clinical study of pamrevlumab (FG-3019) in combination with standard-of-care chemotherapy in patients with locally advanced pancreatic ductal adenocarcinoma (PDAC) were presented in a poster session during the ASCO 2017 Gastrointestinal Cancers Symposium in San Francisco. Pamrevlumab is a fully human monoclonal therapeutic antibody that inhibits connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders.

 

Actelion announced that the MAESTRO study to assess the efficacy, safety and tolerability of macitentan in patients with pulmonary arterial hypertension (PAH) due to Eisenmenger Syndrome did not meet its primary objective.

 

Cellectis announced the publication of a study in Scientific Reports, a Nature Publishing Group journal, describing a novel approach to a CAR design with an integrated environmental signal utilizing oxygen concentration to manipulate the CAR T-cell response. In this report, Alexandre Juillerat, Ph.D. and his collaborators from the Cellectis innovation team designed a new CAR architecture that contains an integrated microenvironment sensor. Low oxygen concentration is recognized as a hallmark of the microenvironment of certain solid tumors. The implementation of the novel oxygen sensitive CAR architecture empowers CAR T-cells with the possibility to auto-regulate (switch on or tune-up) their functions in low oxygen (hypoxic) environments.

 

 

ANALYST RECOMMENDATIONS

 

Barclays analyst Douglas Tsao downgraded CoLucid Pharmaceuticals to “equal-weight” from “overweight,” citing acquisition by Eli Lilly.

 

Guggenheim analyst Louise Chen initiated coverage of Achaogen with a “buy” rating and $30 price target, citing the sales potential for Plazomicin and AKAO’s early stage pipeline will reach sales levels not yet reflected in consensus expectations.

 

Stifel analyst Thomas Shrader increased his price target of Clovis to $86 from $52, citing an acquisition-based target price

 

FBR analyst Rahula Jasuja assumed coverage of the following companies: Achillion Pharmaceuticals with an “outperform” rating and $16 price target; Arena Pharmaceuticals with an “outperform” rating and $6 price target; BioCryst Pharmaceuticals with an “outperform” rating and $8 price target; Genocea Biosciences with an “outperform” rating $17 price target; Trevena with an “outperform” rating and $13 price target.

 

Credit Suisse analyst Alethia Young increased her price target of Biogen to $314 from $312, citing increased Spinraza estimates (2017 sales are now $167M vs. $59M previously).

 

Leerink analyst Geoffrey Porges revised his price target of the following companies: Alexion increased to $217 from $211; Amgen increased to $164 from $163; Biogen decreased to $359 from $360; Celgene decreased to $138 from $139; Gilead increased to $91 from $89; Regeneron decreased to $487 from $492; Vertex decreased to $108 from $111.

 

Credit Suisse analyst Kennen MacKay increased his price target of FibroGen to $47 from $44, citing adding pamrevlumab (FG-3019) in pancreatic cancer to the model following updated data from pamrevulab in neoadjuvant pancreatic cancer presented at ASCO-GI on Friday.