BioShares Biotechnology Clinical Trials (BBC): $20.02, -$0.44, -31.1% YTD

BioShares Biotechnology Products (BBP): $30.22, -$0.32, -1.9% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures pointed to a higher open ahead of a flurry of economic data releases later in the day. Jobless claims, Markit and ISM manufacturing index and vehicle sales data are on the economic
calendar, and Broadcom and Campbell Soup are scheduled to report quarterly results. European markets were trading higher, buoyed by a rally in banks and a recovery by commodity stock after recent falls and Asian stock markets recorded a mixed trading day.
In the forex markets, sterling staged a 1 percent gain against the dollar on the back of strong UK manufacturing PMI data. Oil prices steadied after Saudi Arabia hinted OPEC was moving towards a common position on oil production that some investors think could
support prices. Gold dropped to its lowest in over two months.

 

 

MARKET HIGHLIGHTS

 

Kamada and Kedrion S.p.A. announced the submission of a Biological License Application (BLA) has been filed with the U.S. Food and Drug Administration for a post-exposure treatment for
rabies, a life-threatening condition.  The human anti-rabies immune globulin (IgG) therapy was developed as a collaboration between the two companies. Kamada and Kedrion have a strategic agreement for the clinical development and marketing of the anticipated
new IgG rabies treatment in the U.S.  Kamada will hold the license for the approved product and Kedrion will exclusively market the therapy in the U.S., subject to receiving marketing approval from the FDA.

 

VBI Vaccines is scheduled to present at the 10th Vaccine Congress on Monday, September 5, 2016.  The event is being held at the NH Grand Hotel Krasnapolsky in Amsterdam, the Netherlands. During
the presentation, eVLP Delivery of an Optimized Form of CMV gB Antigen for Prophylactic Vaccination against Congenital CMV, Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, will summarize recent developments in the company’s cytomegalovirus
(“CMV”) vaccine program, including new data that demonstrates the desirable properties of VBI’s eVLP Platform.

 

Cellect Biotechnology provided a corporate update and announced financial results for the second quarter ended June 30, 2016.  Net loss for the second quarter of 2016 was $0.8 million, or $0.01
per share, compared to $1.0 million, or $0.012 per share, in the first quarter of 2016, and $0.6 million, or $0.006 per share, in the second quarter of 2015.  Cash and cash equivalents (including marketable securities) totaled $3.0 million as of June 30, 2016,
compared to $3.1 million on December 31, 2015, and $4.3 million on June 30, 2015.

 

Achaogen has completed patient enrollment ahead of schedule in its Phase 3 EPIC registration clinical trial of plazomicin. Additionally, the Company has closed enrollment in the Phase 3 CARE
trial of plazomicin and expects to report top-line results from both the EPIC and CARE clinical trials early in the first quarter of 2017. Achaogen is developing plazomicin to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant
Enterobacteriaceae (CRE).

 

Aeglea BioTherapeutics announced that its chief executive officer, David G. Lowe, Ph.D., will present at the 2016 Wells Fargo Healthcare Conference in Boston on Wednesday, September 7 at 1:45
p.m. EDT.

 

Eiger BioPharmaceuticals
has been invited to present at the 2016 Gateway Conference being held on Wednesday, September 7 at 1:30 p.m. Pacific Time.

 

Paratek Pharmaceuticals will participate in two upcoming investor conferences. Paratek will present at the Baird’s 2016 Global Healthcare Conference on Wednesday, September 7th, and
the Ladenburg Thalmann 2nd Annual Healthcare Conference on Tuesday, September 27th. 

 

Sunovion Pharmaceuticals and
Cynapsus Therapeutics announced that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for $40.50 per share in cash. The transaction has received unanimous approval by the Board of Directors of both companies
and values Cynapsus at approximately $624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement
reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.

 

Array BioPharma announced that the FDA has accepted its NDA for binimetinib with a target action date under the PDUFA of June 30, 2017. Array completed its NDA submission of binimetinib in late
June 2016 based on findings from the pivotal Phase III NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial in patients with NRAS-mutant melanoma. The FDA also indicated that it plans to hold an advisory committee meeting (ODAC) as part of the review process. As previously
reported, Array is currently preparing for an Application Orientation Meeting (AOM) with the FDA in September 2016, which it expects will include a discussion of the NDA package including clinical risk / benefit.

 

Cytokinetics announced the advancement of omecamtiv mecarbil to Phase III clinical development with a cardiovascular outcomes clinical trial expected to initiate in the fourth quarter of 2016.
Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of patients with chronic heart failure. The decision to proceed to Phase
III development follows the review of results from prior clinical trials, including COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase II clinical trial evaluating omecamtiv mecarbil in patients with chronic
heart failure. Data from COSMIC-HF were first presented in a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2015. COSMIC-HF met its primary pharmacokinetic objective and demonstrated statistically significant improvements
in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. In addition,
Amgen and Cytokinetics have convened meetings with regulatory authorities to inform plans for omecamtiv mecarbil in a Phase III clinical trials program.

 

Amgen and Servier announced an advancement in their cardiovascular collaboration, with Servier’s decision to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure
in Europe, as well in as the Commonwealth of Independent States, including Russia, which were added to the collaboration. The companies also announced the omecamtiv mecarbil Phase III development program will move forward in collaboration with
Cytokinetics. Under the terms of the agreement, Servier will make a $10 million option exercise payment, as well as future milestone and royalty payments, to Amgen. Servier will assume a share of the development costs.

 

Amgen and Boehringer Ingelheim announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836908 (AMG 420), a bispecific T cell engager
(BiTE) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma. BI 836908 (AMG 420) is currently in Phase I studies. BI 836908 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the company was acquired
by Amgen in 2012. Under the provisions of the agreement, Amgen will work with Boehringer Ingelheim to assume responsibility for the clinical development of BI 836908 (AMG 420), transfer manufacturing, and lead global regulatory activity moving forward. Amgen
will also receive worldwide commercialization rights for BI 836908 (AMG 420). Prior to this agreement, Boehringer Ingelheim held global development and commercialization rights. Financial terms of the agreement are not being disclosed.

 

Novo Nordisk announced that the European Commission has approved the expanded use of Xultophy (insulin degludec/liraglutide), the first once-daily combination of a long-acting basal insulin (Tresiba
[insulin degludec]) and a glucagon-like peptide-1 (GLP-1) receptor agonist (Victoza [liraglutide]) in one pen, in adults with Type II diabetes and moderate renal impairment (CrCL 30-59 mL/min). The authorization covers all 28 European Union member states,
Norway and Iceland.

 

Perrigo announced it has received tentative approval from the FDA for the generic version of Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%).

 

Viking Therapeutics announced the presentation of data from a Phase I trial of VK5211, the company’s lead program for muscle and bone disorders, at the 5th Fragility Fracture Network (FFN) Global
Congress 2016, currently underway in Rome, Italy.  The results of this study showed VK5211 to be safe, well tolerated, and to have a predictable pharmacokinetic (PK) profile in healthy women and men age 65 and over.  Also during the conference, the company
will make an oral presentation highlighting its ongoing Phase II study of VK5211 in patients recovering from non-elective hip fracture surgery.  FFN organizers have designated Viking’s VK5211 Phase II study design as one of the conference’s top 15 poster presentations
and will feature it as part of an oral plenary poster presentation session on September 2.

 

Neurocrine Biosciences announced that the FDA has conditionally accepted the proprietary name “INGREZZA” for the Company’s once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine.
The Company has recently announced the submission of a NDA with the FDA for valbenazine in tardive dyskinesia and is also exploring its utility in Tourette syndrome.

 

Cascadian Therapeutics announced that the United States Adopted Names (USAN) Council and the International Nonproprietary Names (INN) Expert Group have approved the nonproprietary name “tucatinib”
for ONT-380, the Company’s lead product candidate for the treatment of advanced, metastatic HER2+ breast cancer.

 

Egalet Corporation announced the completion of a secured debt offering of $40 million. Egalet plans to use the net proceeds from this transaction to repay all outstanding obligations to
Hercules Capital under its existing loan agreement, to support the approval and planned commercialization of ARYMO ER (Morphine Sulfate) extended-release tablets, an abuse-deterrent morphine, to support the development of Egalet-002, an abuse-deterrent,
extended-release oxycodone, and for general corporate purposes. Morgan Stanley & Co. acted as sole placement agent for the transaction.

 

AstraZeneca announced results from the SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol LABA (long-acting beta(2)-adrenergic agonist) safety study showing patients with
controlled and uncontrolled asthma had a comparable risk of serious asthma-related events and a lower risk of asthma exacerbations when formoterol was combined with budesonide versus budesonide alone.

 

Mallinckrodt announced it closed the acquisition of
Stratatech Corporation, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically
enhanced skin tissues. Under Mallinckrodt’s Acquire to Invest operating model, the company will invest in bringing this Phase III cutting edge development product to patients. If approved, StrataGraft could be the first biological “off-the-shelf” skin substitute
product for treatment of severe burns – Stratatech’s proprietary tissue engineering technology produces living tissues designed to mimic human skin and promote tissue regeneration.

 

Genentech, a member of the
Roche Group, announced positive results for TECENTRIQ from the Phase III study, OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel
chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events were consistent with what has been previously observed for TECENTRIQ.
Genentech looks forward to presenting full results at an upcoming medical meeting in 2016.

 

Cerenis Therapeutics announced the presentation of a poster on the positive tolerability and safety findings of its drug candidate CER-001, at the occasion of the European Society of Cardiology
congress, which will be held from the 24(th )to 31(st) August 2016 in Rome. The positive safety and tolerability profile of CER-001 observed in the clinical trial program to date supports its continued development as both a short- (post-ACS population) and
a long-term treatment (HDL-deficient patients).

 

Galenica Group announced that its tender offer to purchase the outstanding shares of common stock of
Relypsa at $32.00 per share, net to the seller in cash, without interest and less any applicable withholding taxes, expired at 12:00 midnight New York time, at the end of the day on Wednesday, August 31, 2016. The tender offer was effected by Galenica’s
indirect wholly owned subsidiary, Vifor Pharma USA.

 

GenSight Biologics announced that the EC, based on a favorable recommendation from the EMA, has granted orphan drug designation (ODD) to the Company’s product candidate GS030 for the treatment
of retinitis pigmentosa. The EMA also granted Advanced Therapy Medicinal Product (ATMP) classification to GS030.

 

Horizon Discovery Group announced it has entered into a co-development and commercialization agreement with
Ventana Medical Systems, a member of the Roche Group. The Agreement covers the development, manufacture and commercialization of cell line derivative materials for use as IHC Reference Standards in cancer tissue diagnostics to support the development
and validation of IHC assays.

 

Medicure announced that it has received approval from the FDA for its new “bolus vial” product format for AGGRASTAT (tirofiban HCl).

 

OncoMed Pharmaceuticals announced the completion of patient enrollment of 207 patients in the randomized Phase II “YOSEMITE” clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment
of first-line metastatic pancreatic cancer. Topline results are expected in the first half of 2017.

 

Biocept announces the grant of a Chinese patent entitled, METHODS AND REAGENTS FOR SIGNAL AMPLIFICATION.  The issued patent corresponds to the current Chinese Patent Application No. 201180056340.0
and covers the use of a novel stain in the detection of rare cells such as CTCs from blood and other biological fluids.  This newly awarded patent works in combination with a patent previously granted to Biocept in China that corresponds to the use of a microchannel
to capture and interrogate rare cells.

 

Biohaven Pharmaceuticals announced that it has provided Series A financing to
Kleo Pharmaceuticals to advance the company’s novel Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Recruiting Molecules (SyAMs). The company plans to develop ARMs and SyAMs to treat cancer and infectious diseases. Both companies were spun
out of intellectual property arising from Yale University. In addition to the financing, the companies entered into a clinical development master services agreement leveraging the strengths of both companies. Kleo has leading expertise in chemistry discovery,
and Biohaven has expertise in pharmaceutical clinical development with its management coming from the pharmaceutical industry including experience at Bristol-Myers Squibb, Pfizer and Alexion. Although the terms of the Series A financing are not disclosed,
Biohaven will take a substantial equity stake in Kleo.

 

Amunix announced that
Versartis has completed enrollment of a Phase III study of somavaratan (XTENylated recombinant growth hormone) in pediatric patients with growth hormone deficiency.

 

Oxford Immunotec Global announced that the U.S. Magistrate Judge in the Company’s patent infringement lawsuit against
Qiagen, Quest Diagnostics and Laboratory Corporation of America Holdings has issued a recommendation denying in substantial part the defendants’ motion to dismiss the Company’s claims. In issuing his recommendation, the magistrate judge
stated, “At this early juncture, the Court concludes that the in vitro aspect of the plaintiff’s tuberculosis test is an ‘inventive concept’ because it improves on prior methods of detecting tuberculosis infection.” The magistrate judge’s recommendation should
now allow the Company to press forward with its case against the three defendants, asserting infringement of its six patents relating to methods for diagnosing TB infection.

 

Halozyme Therapeutics named Mark Gergen as senior vice president and COO, reporting to Dr. Helen Torley, president and CEO.

 

 

ANALYST RECOMMENDATIONS

 

LifeSci Capital analyst David Sherman initiate research coverage of
GeNeuro SA.

 

Leerink analyst Joseph Schwartz decreased his price target of
AMAG Pharmaceuticals to $36 from $40, citing competitive dynamics within the auto-injected drug space have been heavily scrutinized recently in response to heightened awareness of
Mylan‘s EpiPen pricing, and AMAG’s Makena auto-injector may garner similar attention in 2018