BioShares Biotechnology Clinical Trials (BBC): $22.87, +$0.17, +24.2% YTD

BioShares Biotechnology Products (BBP): $38.38, -$0.24, +17.2% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a slightly lower open, as expectations of an interest rate hike next week loomed large. International trade, goods trade balance and consumer credit data are on the economic calendar. European shares extended losses as financial stocks lost ground on concerns over Deutsche bank’s health, and as Aggreko and Casino were weighed down by results. Meanwhile, Asian stocks ended higher. The dollar inched higher against a basket of trade-weighted peers, while gold slipped to a three-week low. Oil prices advanced ahead of inventory data and comments from senior oil officials.

 

 

MARKET HIGHLIGHTS

 

Advaxis announced Al Blunt, M.D., has joined the company as Vice President of Medical. Dr. Blunt joins Advaxis from Covance, a leading global clinical research organization and drug development service company, where he was Executive Medical Director for Oncology.

 

Evogene announced that Mr. Yuval Ben-Galim, Evogene’s COO, will present at the CannaTech 2017 annual cannabis summit, taking place in Tel-Aviv, Israel on March 21st. The summit will focus on acceleration of cannabis innovation, with wide spectrum of global industry leaders spanning from science to government.

 

TiGenix NV has received positive feedback from the U.S. Food and Drug Administration (FDA) on an improved protocol for its global Phase III trial for the treatment of complex perianal fistulas in Crohn`s disease patients.  Based on the minutes from a meeting with the FDA on January 19, 2017, the Agency has agreed to an improved protocol for the global Phase III trial of Cx601. With these current amendments, the FDA has agreed that the BLA could be filed based on the efficacy and safety follow-up of patients assessed at week 24, instead of week 52. Furthermore, the FDA has agreed to accept fewer patients than originally planned in the study, and has endorsed a broader target population that will ultimately facilitate the recruitment process. With these adjustments, the study will benefit from an expedited recruitment process that should lead to shorter timelines, an earlier filing, and the possibility of an earlier approval in the U.S. As a result of these modifications, the trial design is even more similar to the European ADMIRE-CD than it was before.

 

Innate Pharma SA reported consolidated financial results for the year ended December 31, 2016.  Revenue and other income amounting to €65.7m (€25.1m in 2015). This amount mainly results from licensing revenue (€56.2m) and from research tax credit (€9.1m). The net profit for 2016 amounts to €12.6m to be compared to a loss of €6.7m for 2015.  Cash, cash equivalents and financial instruments amounting to €230.7m (million euros) as of December 31, 2016 (€273.7m as of December 31, 2015), including non-current financial instruments (€33.0m).

 

Santhera Pharmaceuticals reported the Group`s audited financial results for 2016. The Company generated net revenues of CHF 19.0 million (+340% year-on-year) from sales of its lead product Raxone® for the treatment of Leber`s hereditary optic neuropathy (LHON). The operating result amounted to CHF -33.1 million (2015 comparable: CHF -23.9 million) and the net result was CHF -35.4 million. Santhera submitted a Marketing Authorization Application (MAA) for Raxone for the treatment of Duchenne muscular dystrophy (DMD) in the EU and Switzerland, started the SIDEROS phase III trial in DMD and made significant progress in all other product development programs. Cash and cash equivalents by the end of February 2017 amounted to CHF 100.8 million.

 

Aurinia Pharmaceuticals announced that its late-breaking abstract for voclosporin has been accepted for oral presentation at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking place April 18-22, 2017 in Orlando, FL. The oral presentation, titled “Treatment of Active Lupus Nephritis with Voclosporin: 48 Week Data from the AURA-LV Study,” will be made by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor, Clinical Nephrology at the Ohio State University, on Thursday, April 20, 2017 from 4:00 p.m. – 5:30 p.m. ET.

 

ASPiRA LABs, a Vermillion company, today announced it has attained out-of-state provider status with Medi-Cal, California’s Medicaid program, for OVA1®/Multivariate Index Assay (MIA). ASPiRA Labs is the sole source provider for OVA1 (MIA), an FDA cleared, ACOG recommended1 ovarian cancer risk assessment test. With ASPiRA Labs’ out-of-state provider status with Medi-Cal, OVA1 (MIA) is now available to over 12 million Medi-Cal beneficiaries, representing approximately a third of the covered lives in California.

 

Foamix Pharmaceuticals will provide a corporate overview and business update at the 29th Annual ROTH Conference on Monday, March 13th @ 10:30am Pacific Time.

 

Alcobra will participate in two upcoming investor healthcare conferences during March.  The 29th Annual ROTH Conference on Tuesday, March 14th @ 4pm Pacific Time, and the Oppenheimer & Co. 27th Annual Healthcare Conference on Wednesday, March 22nd @ 9:45am Eastern Time.

 

Albireo Pharma will host a conference call and live audio webcast on Tuesday, March 14 at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2016, and provide a business update.

 

VBL Therapeutics will provide a corporate overview at the 29th Annual ROTH Conference on Tuesday, March 14th @ 7:30am Pacific Time.

 

TRACON Pharmaceuticals will present at the 29th Annual Roth Conference at 8:30 am PDT on Monday, March 13, 2017, at the Ritz Carlton in Dana Point, CA.

 

Reuters reported that President Donald Trump said he was working on a "new system" to lower pricing in the drug industry. "I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!" Trump tweeted.

 

Mesoblast announced that the FDA has granted a Fast Track designation for the use of its cell therapy, MSC-100-IV, to achieve improved overall response rate in children with steroid refractory acute Graft Versus Host Disease (aGVHD).

 

Revance Therapeutics announced the completion of patient enrollment in two pivotal trials of the company’s SAKURA Phase III program for its investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) for the treatment of moderate to severe glabellar lines in adults. Glabellar line treatment is the most popular aesthetic procedure for botulinum toxin and is estimated to have represented nearly $1 billion of the global market in 2015. Revance’s Phase III program is comprised of two pivotal trials evaluating the efficacy, safety and duration of RT002, as well as a long-term safety trial, the latter of which continues to enroll patients. The company expects to report topline results from both pivotal Phase III trials in the fourth quarter of 2017.

 

Esperion Therapeutics announced the initiation of a Phase II clinical study (1002-038) to assess the efficacy and safety of triplet oral therapy with bempedoic acid, ezetimibe and atorvastatin in patients with hypercholesterolemia. This non-registrational study will enable the Company to explore the potential market dynamics of these complementary oral LDL-C lowering therapies together. Top-line results are expected by the fourth quarter of 2017.

 

Aeterna Zentaris announced that the Pediatric Committee (“PDCO”) of the EMA agreed to the Company’s Pediatric Investigation Plan (“PIP”) for Macrilen and agreed that the Company may defer conducting the PIP until after it files a MAA seeking marketing authorization for the use of Macrilen for the evaluation of adult growth hormone deficiency.

 

Trovagene announced that a patient case series featuring use of the Company’s Trovera EGFR urine-based liquid biopsy test was recently published in Lung Cancer. The publication, titled "Longitudinal Monitoring of ctDNA EGFR Mutation Burden from Urine Correlates with Patient Response to EGFR TKIs: A Case Series," demonstrates the value of urine ctDNA EGFR testing to aid in the diagnostic work-up and clinical management of patients with non-small cell lung cancer.

 

RedHill Biopharma updated that Concordia International, RedHill’s co-promotion partner for the gastrointestinal drug Donnatal, announced that a U.S. district court granted a Concordia subsidiary treble damages related to false claims made by Method Pharmaceuticals and its principal owner.

 

Novelion Therapeutics announced that the United States Patent Trial and Appeal Board (PTAB) issued a written decision in an Inter Partes Review proceeding affirming the patentability of all claims on U.S. 7,932,268 and U.S. 8,618,135 lomitapide dosage regimen patents.

 

Biohaven Pharmaceutical Holding Company announced that it has completed the second tranche of its previously disclosed $80 million private financing. Together with the proceeds raised under the first tranche, Biohaven has now raised over $100 million in private capital since its inception.  The financing was led by Venrock and joined by other leading biotech investors including Vivo Capital, RA Capital Management, Aisling Capital, Rock Springs Capital, John W. Childs, Greg Bailey, Knoll Capital Management, Osage University Partners, Aperture Venture Partners, Connecticut Innovations, and Litmore Capital. All investors who participated in the first tranche also participated in the second tranche.

 

Bioversys and Aptuit announced the start of a joint collaboration aimed at the identification and validation of novel targets and molecules for Gram-negative bacteria.  Aptuit and BioVersys hope that innovative approaches can address antibiotic resistance in the treatment of serious infections.

 

Swedish Orphan Biovitrum announced that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin capsules (2 mg, 5 mg, 10 mg and 20 mg). The FDA approval follows the already existing approval by the EMA for in-use storage at room temperature. In addition to this, FDA also approved an extended shelf life for Orfadin capsules 20 mg, from 24 to 36 months.

 

GW Pharmaceuticals announced the appointment of Scott Giacobello as Chief Financial Officer on 6 March 2017. Reporting to GW’s Chief Executive Officer Justin Gover, Mr. Giacobello will be based at the Company’s U.S. headquarters in Carlsbad, California. Related to this appointment, on 6 March 2017 Adam George, GW’s Chief Financial Officer since 2012, became Managing Director – UK, a newly-created executive role with broad leadership responsibilities for UK operations, also reporting to Justin Gover.

 

Cyclenium Pharma and The Hospital for Sick Children (SickKids) have entered into a research agreement designed to discover novel modulators for multiple new and existing biological targets of pharmacological interest across a variety of disease areas, including cardiovascular, immunology and oncology. This collaboration will provide SickKids researchers with immediate access to Cyclenium’s proprietary QUEST Library of next generation macrocyclic molecules and associated chemical hit and lead optimization capabilities. The initial objective of these exploratory efforts is to identify compounds capable of interacting with specific therapeutic targets being studied at SickKids, thereby providing tools to improve the understanding of their involvement in the pathophysiology of specific diseases, with the ultimate goal of discovering novel therapeutic or diagnostic agents.

 

Cyclacel Pharmaceuticals announced the publication of a peer-reviewed journal article featuring the company’s cyclin dependent kinase 2/9 (CDK2/9) inhibitors. In an article published in the Journal of National Cancer Institute (JNCI), preclinical data demonstrated that both Cyclacel’s CYC065, a second-generation, clinical stage, CDK2/9 inhibitor, and CCT68127, a pre-clinical stage CDK2/9 inhibitor, demonstrated prominent antitumor activity against lung cancer through anaphase catastrophe, a novel, cancer specific mechanism of action.

 

BeiGene and Guangzhou Development District announced that BeiGene and GDD and its affiliate Guangzhou GET Technology Development Co have entered into a definitive agreement to establish a state-of-the-art commercial-scale biologics manufacturing facility in Guangzhou, Guangdong Province, China. The joint venture (JV), BeiGene Biologics Co, will also provide funding for research and development of biologic drug candidates in China. Total direct investments are expected to be RMB2.2 billion ($330 million).

 

Milestone Pharmaceuticals USA announced the appointment of Joseph G. Oliveto as President and Chief Executive Officer, effective immediately. His appointment follows a recent, successful outcome from the company’s Phase 2 study of lead candidate etripamil for the acute treatment of paroxysmal supra-ventricular tachycardia (PSVT), a potentially debilitating cardiac arrhythmia. Mr. Oliveto brings more than 25 years of pharmaceutical and biotech experience across the areas of drug development, commercialization, manufacturing and business development to Milestone. Philippe Douville, Ph.D., who founded the company and served as CEO, will now assume the newly created position of Chief Scientific Officer.

 

ObsEva SA announced the initiation of its Phase III clinical program evaluating the efficacy and safety of nolasiban to improve pregnancy and live birth rates in women undergoing ART. The study is being conducted in 10 European countries.

 

Supernus Pharmaceuticals announced that it has entered into a settlement agreement with Zydus Pharmaceutical  and Cadila Healthcare Limited involving the ongoing patent litigation regarding Zydus’ ANDA seeking approval to market generic versions of Supernus’ Trokendi XR (extended-release topiramate) capsules. The settlement agreement permits Zydus to begin selling a generic version of Trokendi XR on January 1, 2023, or earlier under certain circumstances. The agreement will be submitted to the applicable governmental agencies.

 

Actelion announced that the EC has granted marketing authorization for the use of Ledaga (chlormethine gel) 160 micrograms/g for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF type CTCL) in adult patients.

 

Immunicum AB announced that a new patient has been enrolled in the Phase I/II Gastrointestinal Stromal Tumor (GIST) study following the study protocol amendment, which was recently approved by the ethical committee and the Swedish Medical Products Agency. The study is conducted in collaboration with the Karolinska Institute and investigates the safety and efficacy of INTUVAX® in combination with tyrosine kinase inhibitors in patients with incurable GIST.

 

Pacira Pharmaceuticals announced that it intends to offer, subject to market and other conditions, $300 million aggregate principal amount of convertible senior notes due 2022 in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Pacira also intends to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $45 million aggregate principal amount of notes.      The terms of the notes, including the interest rate, initial conversion rate and other terms, will be determined by negotiations between Pacira and the initial purchasers of the notes. Pacira intends to use a portion of the net proceeds to enter into privately negotiated agreements with certain holders of its 3.25% convertible senior notes due 2019 to exchange their 2019 Notes for a combination of cash and shares of Pacira common stock. The remaining net proceeds will be used for general corporate purposes, including working capital, research and development expenditures and the license or acquisition of complementary products and/or technologies.

 

RepliCel Life Sciences announced the company has retained The FreeMind Group, a premier international firm that assists life science organizations in securing non-dilutive funding from granting agencies and private foundations. RepliCel aims to secure non-dilutive capital to support research, clinical development, and/or manufacturing priorities to accelerate value creation and the commercialization of its products.

 

AXIM announced enrollment of 40 patients and commencement of its Phase II clinical trial for the treatment of irritable bowel syndrome (IBS) with the company’s CanChew Plus CBD gum. The study is being conducted by Renger Witkamp, Professor and Chair in Nutrition and Pharmacology, at Wageningen University in the Netherlands.

 

 

ANALYST RECOMMENDATIONS

 

HC Wainwright analyst Swayampakula Ramakanth initiated coverage of OSE Immunotherapeutics with a “buy” rating and €12 price target, citing OSE Immunotherapeutics is a French clinical-stage biotechnology company developing novel immunotherapies against both cancer and autoimmune diseases.

 

Deutsche Bank analyst Gregg Gilbert decreased his price target of Endo International to $18 from $20, citing lower sales for the generics business, partially offset by margin expansion driven by ENDP’s restructuring initiatives.

 

Rodman & Renshaw analyst Joseph Pantginis initiated coverage at Fibrocell Science with a “buy” rating and $2 price target, citing technological expertise in fibroblasts and bringing gene therapy to the forefront.

 

Janney analyst Paul Knight upgraded Foundation Medicine to “neutral” from “sell,” citing easy Q1 earnings comps as a result of Palmetto GBH payments and reduced expectations.

 

Citi analyst Yigal Nochomovitz increased his price target of Lexicon Pharmaceuticals to $28 from $24, citing derisked late stage diabetes drug with underappreciated upside in T1D/T2D, a now approved drug in Xermelo with a well-defined target market and clean label, and a discovery engine that has now proven it can go the distance from bench to approval.

 

Oppenheimer analyst Jay Olson downgraded NeuroDerm to “perform” from “outperform,” citing valuation.

 

Jefferies analyst Biren Amin downgraded Oncobiologics to “hold” from “buy” and decreased his price target to $3 from $7, citing ONS’ inability to execute on a partnership to date, ONS is unlikely to partner its biosimilar assets, and may be unable to fund its pipeline.

 

Chardan analyst Gbola Amusa decreased his price target of Ophthotech to $4 from $15, citing the effects of the Fovista failure.

 

FBR analyst Rahul Jasuja increased his price target of Aduro to $23 from $20, citing LADD program is no longer under regulatory hold, and we see increased potential in STING and B-select for combination approaches.

 

Roth analyst Mark Breidenbach re-initiated coverage of Aduro with a “buy” rating and $11 price target, citing the company has assembled an impressive collection of immuno-oncology assets and has demonstrated encouraging proof-of concept clinical results in mesothelioma.