BioShares Biotechnology Clinical Trials (BBC): $21.13, +$0.12

BioShares Biotechnology Products (BBP): $31.58, +$0.03

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed as the main focus remained on the global central banks meet at Jackson Hole this week where U.S. Federal Reserve Chair Janet Yellen might provide clues on
a possible interest rate hike. Building permits, monthly home prices and existing home sales will be closely watched to gauge strength of the economy. Hewlett-Packard marks an end of the earnings season and is expected to report after the closing bell. European
shares rose, lifted by gains in Sweden’s hygiene product maker SCA and British advertising group WPP, while the FTSE 100 was dragged lower by British miner Glencore. Asian stocks closed mixed as strong U.S housing data overnight increased the chances of an
interest rate increase, prompting some investors to take profits. The dollar consolidated, while gold edged lower. Brent oil fell after industry data from the American Petroleum Institute showed an unexpected increase in U.S. crude stocks.

 

 

MARKET HIGHLIGHTS

 

BioLife Solutions announced that its clinical grade CryoStor freeze media has been incorporated into the manufacturing process for Invossa, a cell-mediated gene therapy for knee osteoarthritis
to be marketed by Kolon Life Science.

 

Insys Therapeutics reported that the Phase III trial for the Buprenorphine Sublingual Spray met its primary endpoint. The trial  was a multicenter, randomized, double-blind, multiple-dose, placebo-controlled
study evaluating the efficacy and safety of three dosing regimens of Buprenorphine Sublingual Spray (0.5 mg three times daily (“tid”), 0.25 mg tid, or 0.125 mg tid), and/or matching placebo in subjects with moderate to severe postoperative pain after bunionectomy. 
322 subjects were randomized.  As agreed with the FDA, the primary efficacy endpoint in this study was the Summed Pain Intensity Difference relative to baseline over a period of 48 hours (SPID-48).  The patient assessment of pain intensity utilized a numeric
pain scale (11-point scale with 0 = no pain to 10 = worst possible pain).

 

SCYNEXIS announced that the FDA has granted orphan drug designation to the company’s novel triterpenoid broad-spectrum antifungal agent, SCY-078, for the treatment of invasive Aspergillus infections.

 

Clovis Oncology announced that the FDA has accepted Clovis’ NDA for accelerated approval of rucaparib and granted priority review status to the application with a PDUFA date of February 23, 2017.
In late June 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved
test), and who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015. Following the announcement,
Mizuho analyst Eric Criscuolo increased his price target to $23 from $15;
Credit Suisse
analyst Kennen MacKay increased his price target to $19 from $14;
JP Morgan analyst Cory Kasimov increased his price target to $23 from $13;
SunTrust analyst Peter Lawson increased his price target to $30 from $25;
Janney
analyst Roy Buchanan increased his fair value estimate to $30 from $21.  

 

Pfizer announced that it has entered into an agreement with
AstraZeneca to acquire the development and commercialization rights to its late-stage small molecule anti-infectives 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 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. Under the terms of the agreement, Pfizer will make an upfront payment of $550 million
to AstraZeneca upon the close of the transaction and a deferred payment of $175 million in January 2019. In addition, AstraZeneca is eligible to receive up to $250 million in milestone payments, up to $600 million in sales-related payments, as well as tiered
royalties on sales of Zavicefta and ATM-AVI in certain markets.

 

OraSure Technologies announced that it has been awarded a contract for up to $16.6 million in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant
Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) to advance the Company’s rapid Zika tests.
Following the news, Canaccord analyst Mark Massaro increased his price target of OraSure Technologies
to $10 from $9.

 

Oculus Innovative Sciences announced it has received a new 510(k) clearance from the FDA for the company’s new post-dermal-procedures product.

 

Idera Pharmaceuticals announced the presentation of new pre-clinical data that demonstrates the novel gene-silencing mechanism of action of the third generation antisense (3GA) technology platform.

 

Inotek Pharmaceuticals announced the completion of the active recruitment phase of MATrX-1, the first pivotal Phase III trial of trabodenoson for the treatment of glaucoma. Trabodenoson, the
company’s lead clinical candidate, is a first-in-class selective adenosine A(1) mimetic under investigation for reduction of intraocular pressure (IOP) which has been observed in Phase II clinical trials to reduce IOP. Top-line data from the MATrX-1 study
are expected in December 2016.

 

BioPharmX announced that the first subject has been enrolled in its Phase IIb clinical trial assessing the efficacy and safety of BPX-01 for the treatment of acne vulgaris. The study is formally
known as the OPAL (tOPicAL Minocycline Gel) study.

 

RegeneRx Biopharmaceuticals announced that its U.S. joint venture,
ReGenTree has received permission from the FDA to proceed with a second Phase III clinical trial using RGN-259 to treat patients with dry eye syndrome (DES).

 

Mallinckrodt announced that it has entered into a definitive agreement under which it will sell its Nuclear Imaging business to IBA Molecular (IBAM), for approximately $690 million before tax
impacts, including up-front and contingent consideration and the assumption of long-term obligations.

 

Corium International announced receiving favorable written feedback from the FDA on the company’s pre-IND submission for once-weekly transdermal Corplex Memantine. Following review of Corium’s
pre-IND submission, which included summary results from a Phase I pharmacokinetic (PK) study of the product candidate, the FDA concurred with the company’s development plans, including its proposal for pivotal studies based on the demonstration of bioequivalence,
or BE, between the Corplex Memantine Transdermal Delivery System (TDS) and oral Namenda XR(R) (memantine HCl) extended release capsules.

 

Cardax announced that it has launched its first commercial product, ZanthoSyn, a safe anti-inflammatory for general health.

 

Cumberland Pharmaceuticals will begin distributing Ethyol (amifostine) for injection to U.S. wholesalers. Ethyol is an FDA approved cytoprotective drug indicated to reduce the incidence of xerostomia
in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

 

AMRI announced that it entered into a non-exclusive commercial license agreement with the Broad Institute of MIT and Harvard for the use of CRISPR-Cas9 gene editing technology and has completed
several projects for its customers. The company will continue to use the technology to enhance its drug discovery service offerings and internal research and development. Financial terms were not disclosed.

 

Photocure announced that its partner and exclusive distributor,
Juno Pharmaceuticals, have received marketing authorization approval (MAA) for Hexvix in Australia. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales
team. Hexvix is Photocure’s flagship product used to aid in the diagnosis and management of bladder cancer. Under the terms of the agreement, with the MAA approval in Australia, Photocure will receive EUR 250,000 in milestone payments.

 

Caisson Biotech announced the issuance of a new patent, U.S. patent 9,370,583, by the USPTO for long lasting recombinant heparosan Factor VIIa conjugate. The naturally occurring polysaccharide,
heparosan, has proven to be as effective as polyethylene glycol (PEG) in prolonging the half-life of haemophilia FVIIa, but retains significantly higher activity (48 ± 4)%, as compared to (27 ± 1)% for a corresponding PEG conjugate. Results were presented
at the recent World Federation of Hemophilia World Congress Conference.

 

Telesta Therapeutics announced that it has executed a binding Agreement, subject to shareholder approval, to be acquired by
ProMetic Life Sciences for consideration of $0.14/Telesta share, payable in freely tradable shares of ProMetic Life Sciences. The actual number of ProMetic shares payable per Telesta common share, will be calculated based on the 5-day volume-weighted
average price of ProMetic shares, for the 5 days immediately preceding the date on which the Court ordered plan of arrangement becomes effective if shareholders vote to approve this transaction.

 

Profounda announced that the drug Impavido (miltefosine) was used to successfully treat 16 year old patient Sebastian DeLeon at Florida Hospital for Children, in Orlando with an infection of
Naegleria fowleri (commonly known as the “Brain eating Amoeba”). Impavido is the first and only oral treatment for visceral, mucosal and cutaneous leishmaniasis (a rare tropical parasitic disease) approved by the FDA and the first Rx product launched in the
U.S. by Profounda, Inc.  Leishmaniasis is the second leading parasitic cause of death in the world after malaria and is rare in the USA but we see 15-30 cases per year.  Recently, Impavido has been recommended by the CDC for treating Primary Amebic Meningoencephalitis
(PAM), the brain infection caused by the water-born amoeba Naegleria fowleri.

 

N1 Technologies announced that the company has filed a new Biotech Patent with the USPTO for its VIRITRON VPN Bacteriophage Treatment for Pneumonia.

 

Interpace Diagnostics reported that the Company has launched a new version of their AccuCEA product called “Insights” for Gastroenterologists who focus on diagnosing and treating pancreatic cancer.

 

Rosetta Genomics announced that the Company has entered into a services agreement with an unnamed global pharmaceutical company to provide Fluorescence in Situ Hybridization (FISH) testing services
for a clinical study the pharmaceutical company is conducting in prostate cancer.

 

OncoMed Pharmaceuticals announced the completion of its previously announced underwritten public offering of 6,325,000 shares of its common stock at a public offering price of $10.00 per share,
which includes the exercise in full of the underwriters’ right to purchase up to an additional 825,000 shares of common stock. All shares in the offering were sold by OncoMed, with gross proceeds to OncoMed of approximately $63.3 million and net proceeds of
approximately $59.2 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Leerink Partners acted as sole book-running manager for the offering. Wells Fargo Securities and
JMP Securities acted as co-managers.

 

ACADIA Pharmaceuticals announced that the underwriters for the Company’s previously announced public offering have fully exercised their option to purchase an additional 909,090 shares. All 6,969,696
shares sold in the offering were offered by ACADIA at a price to the public of $33.00 per share, for total gross proceeds to ACADIA of approximately $230.0 million before deducting underwriting discounts and commissions and other offering expenses payable
by ACADIA. J.P. Morgan Securities, Goldman Sachs and BofA Merrill Lynch acted as the joint book-running managers for the offering.
Cowen, Piper Jaffray and Needham & Company acted as co-managers for the offering. In other company news, ACADIA Pharmaceuticals announced the appointment of Todd Young as Executive Vice President, CFO, effective August 22, 2016.

 

Exelixis announced that it has called for redemption approximately $48.1 million of its 4.25% Convertible Senior Subordinated Notes due 2019, representing all remaining notes outstanding. The
redemption will be made in accordance with the terms of the indenture governing the notes and the terms of the redemption notice.

 

 

ANALYST RECOMMENDATIONS

 

Piper Jaffray analyst David Amsellem increased his price target of
Mallinckrodt to $112 from $103, citing that visibility is high for sustainable growth for Acthar.

 

Leerink analyst Geoffrey Porges decreased his price target of
Gilead Sciences to $112 from $114, citing updates to HIV forecasts and the inclusion of recent company disclosures in its second quarter 10-Q.