Sector News

Novartis BAF312 Lowers the Risk of MS Disability Progression
The results from Phase-3 clinical trial, evaluating Novartis’ (NYSE: NVS) treatment BAF312 meant for curing secondary progressive multiple sclerosis (SPMS) showed a 21% reduction compared to placebo in the risk of confirmed disability progression (p= 0.013), the primary endpoint. The result was showed at the 32nd Congress of the European Committee for treatment and Research in Multiple Sclerosis in London. The risk reduction was recorded at Month 3 of the trial. The company added that the risk reduction at Month 6 was higher. The treatment also beat placebo by over 12 and 24 months as measured by annualized relapse rate, which is measure of the percentage change in brain volume and the change from baseline in the volume to T2 lesions. Nonetheless, it failed to beat placebo in the timed 25-foot walk test. The Company plans to discuss the outcome with regulatory authorities.
Novan Set for an IPO
Durham NC-based Pharma Company, Novan (Pending: NOVN), which develops dermatology treatments would make an IPO of 3.75 million shares of common stock at $11-13. The drug-maker’s lead product is SB204, meant to cure acne vulgaris. The results of two phase-3 clinical tests are due in the first quarter of the next year. If the tests are successful, a new drug application (NDA) would on the pipeline by late next year. Some of the other pipeline candidates include SB206, and SB208. Both are phase 2 candidates.  While the former is intended for viral skin infections, the latter is meant to cure fungal infections of the nails. Financials: For the first six months of the current year, the company posted a net loss of $29.2 million (-170%), having an operating expenses of $29.2 million. Cash Burn stood at $22.1 million (-159.5%).
Community Health Services Considering Sale
Shares of  Community Health Services (NYSE: CYH) vaulted during late hours trading on Friday after a Bloomberg report sparked off a speculation that the hospital operator could explore selling itself. The stock jumped more than 20%, ending the day with 15.7% gain. Shares, however, are down 54%, year-to-date. Nevertheless, the report said that a possible sale could be an uphill task as the company’s balance sheet has a high level of debt even as it grapples with a number of operational issues.

AC Immune Set for an IPO
The Lausanne Switzerland-based biopharma firm, AC Immune SA (Pending ACIU) would offer an IPO of 4,545,456 common shares at $11-13. The company develops treatments for neurodegenerative illnesses linked to protein misfolding. Its lead candidate, crenezumab, meant for treating Alzheimer’s disease, is at present going through Phase-3 trials. The drug maker is collaborating with Genentech (OTCQX: RHHBY) for developing the treatment. Some of the other Alzheimer disease treatments include ACI-24, which is an anti-Abeta vaccine and ACI-35, an anti-pTau vaccine. Both therapies are early-stage candidates. Financials for the first six months of 2016: Revenue $20.5 million (+ 42%); operating expenses $13.8 million (+54.1%); Net Income $6.8 million (+20%); Operating Cash Flows ($7.2 million) (-144.8%). All lead candidates are being developed with the company’s SupraAntigen platform.
Johnson & Johnson Acquires Abbot Medical Optics for $4.3 B
Healthcare giant, Johnson & Johnson (JNJ) signed an agreement with Abbott Laboratories (ABT) to acquire its Medical Optics business for $4.325 billion in an all-cash transaction. The unit, which includes three business categories: cataract surgery, consumer eye health, and laser refractive surgery– generated a revenue of $1.1 billion last year. The deal is likely to close in the first quarter of 2017. The acquisition is expected to mildly boost JNJ’s non-GAAP earnings in FY 2017.
Concordia Shares Nosedive amid Talks of a Cost Containment Bill
Shares of Concordia International (CXRX) nosedived about 18% after news broke that the British Parliament is set to introduce a bill which would aim at restricting National Health Service (NHS) costs for medical supplies and services. The bill dubbed as the Health Service Medical Supplies (Costs) Bill would revise and strengthen existing provisions of the National Health Service Act 2006. Market participants fear that the move would hurt drug-makers. In the fiscal 2015, more than 40% of the revenue was generated outside the U.S. market with the U.K. contributing a major part of the top-line growth. In Q1, the company’s international unit accounted for more than 61% of revenues.

AstraZeneca Announces Successful Outcome of a Phase-3 Clinical Trial on Diabetes Treatment
AstraZeneca (AZN) announced last week that it has successfully completed a Phase-3 clinical trial of treatment, Duration-8, meant to control type 2 diabetes. The treatment offers once-a-week 2mg injections of BYDUREON and once-a-day oral 10 mg pill FARXIGA. The therapy is believed to be a big improvement over existing medicines meant for curing type 2 diabetes. The combination successfully met its goal of substantially lowering HbA1c levels from baseline compared to standard-of-care therapy with the individual drugs. Statistically, the clinical trial also showed that patients experienced significantly greater weight loss and reduction in systolic blood pressure compared to those receiving standard care therapy.
European Medicine Agency Approves BI & Lilly’s Type 2 Diabetes Treatment
The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) gave a positive opinion for a type 2 Diabetes treatment Glyxambi jointly developed by Boehringer Ingelheim and Eli Lilly’s (LLY) for adults. The treatment is a single pill fixed dose, which is a combination of Jardiance, a sodium glucose co-transporter-2 (SGLT2) inhibitor and Trajenta, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It was jointly developed under the companies’ Diabetes Alliance.  Typically it takes about 60 days for the European Commission to take a final call on a treatment.
Roka Signs $22.5 Million Private Equity Placement
Roka Bioscience (NASDAQ) signed a securities purchase agreement for a private placement of about 22,500 share of series A preferred stock. Each Series A share is convertible into about 1,428 shares of common stock at around 70 cents. Buyers would also get one five-year warrant to purchase 1,428 shares of common stock at 70 cents for each share purchased. The closing date September 21. Proceeds would be used for general corporate purposes.
Capricor Prices Equity Offering
Capricor Therapeutics (NASDAQ: CAPR) priced its IPO of 3 million shares of common stock at $3.20. The closing date is September 21. In a concurrent registered direct offering, existing shareholder Cedars-Sinai Medical Centre would purchase 312,500 shares at $3.20. Net proceeds of the offering would be about $8.7 million.
Immune Pharma Signs $20 Million Funding Deal for Subsidiary Maxim Pharmaceuticals
Immune Pharmaceuticals’ (NASDAQ: IMNP) board of directors agreed on making its subsidiary MAXIM Pharmaceuticals as the entity in-charge to develop, commercialize, and hold the intellectual property linked to Amiket and  other ache and neurology assets. The company signed an agreement with a syndicate of healthcare investors under which it will purchase up to $20 million of Maxim’s capital stock. An initial investment of $5 million will be made in the next thirty days. Amiket, a Phase-3 drug is a topical analgesic cream for curing peripheral neuropathies.

Aerie Pharma Raises Equity Offering to $75 Million
Aerie Pharmaceuticals (NASDAQ: AERI) increased the size of its public offering to $75 million at $29.50 a share. The closing date is September 21. After raising $50 million through At-the-Market (ATM) event with Cantor Fitzgerald, the drug-maker would now raise $125 million before costs. The proceeds would be used for general corporate purposes.

Patent Infringement Case: Court Rules against Lialda
The U.S. District Court for the District of Delaware ruled in favor of India-based would-be generic firm Cadila Healthcare Ltd/Zydus Pharmaceuticals in Shire Plc’s (NASDAQ: SHPG) lawsuit. The drug maker alleged infringement of its U.S. patent No. 6,773,720 covering ulcerative colitis med Lialda. However, Shire is not ready to give up the case. It is likely to appeal against the ruling. Lialda contributes about 9% of Shire’s Product sales. Zydus is Cadila’s U.S. unit.

APPROVALS

European Medicine Agency Approves BI & Lilly’s Type 2 Diabetes Treatment
The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) gave a positive opinion for a type 2 Diabetes treatment Glyxambi jointly developed by Boehringer Ingelheim and Eli Lilly’s (LLY) for adults. The treatment is a single pill fixed dose, which is a combination of Jardiance, a sodium glucose co-transporter-2 (SGLT2) inhibitor and Trajenta, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It was jointly developed under the companies’ Diabetes Alliance.  Typically it takes about 60 days for the European Commission to take a final call on a treatment.

European Medicines’ Agency Approves Amgen’s Parsabiv  
The European Medicines Agency’s Committee for Medicinal Products for Human use (CHMP) gave a positive view of Amgen’s (NASDAQ: AMGN) lead candidate Parsabiv, a treatment for adult patients with chronic kidney disease on hemodialysis. If the treatment gets the final approval, it would be the first calcimimetic agent, which could be administered intravenously three times a week after the end of dialysis session. In August the drug-maker got a Complete Response Letter (CRL) from the FDA related to its marketing application in the U.S.

European Medicines’ Agency Committee Approves Pfizer’s Breast Cancer Treatment
The European Medicines’ Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive view of Pfizer’s (NYSE: PFE) breast cancer treatment, IBRANCE. The agency said that the treatment could be used in combination with an aromatase inhibitor [i.e., AstraZeneca’s (NYSE:AZN) Arimidex (anastrozole)] and in combination with fulvestrant (AZN’s FASLODEX) in women who have received prior endocrine therapy. The treatment received FDA approval in 2015.

Insider Buys

Adamas Pharmaceuticals (ADMS)- MDV IX LP, a 10% owner, bought 62,977 shares in three separate transactions. MDV IX bought 54,537 shares at $16.43; 200 shares at $16.50; and 8,240 shares at $16.81. MDV IX LP now owns 4,031,804 shares of ADMS.

Insider Sells

Illumina (ILMN)- Marc Stapley, EVP & Chief Administrative Officer, sold 1,270 shares at $172.87. The total value of the transaction was $219,543. Stapley still owns 32,746 shares of ILMN. Daniel Bradbury, Director, sold 600 shares at $171.25. The total value of the transaction was $102,748. Bradbury still owns 16,465 shares of ILMN.

Omeros (OMER)- Marcia S. Kelbon, VP Patent and General Counsel, sold 16,000 shares at $10.91. The total value of the transaction was $174,578. Kelbon still owns 163,597 shares of OMER.

Chimerix (CMRX)- John M. Leonard, Director, sold 5,000 shares at $5.03. The total value of the transaction was $25,163. Leonard does not own any shares of CMRX.

Big Movers

NYSE- Valeant Pharmaceuticals International (VRX) shares were among the major movers on the NYSE. The stock closed 0.33% lower.

NASDAQ- Revance Therapeutics (RVNC) shares were among the major gainers on the NASDAQ. The stock closed 18.89% higher. Ocera Therapeutics (OCRX) ended the day 16.01% higher. Depomed (DEPO) ended the day 14.60% higher. Novavax (NVAX) shares were among the major losers on the NASDAQ. The stock closed 84.53% lower. Concordia International (CXRX) ended the day 18.31% lower. Oncobiologics (ONS) ended the day 9.62% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 2.86% higher.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 5.56% lower.

Secondary Offerings

No secondary offerings to report.

IPOs

Sancilio Pharmaceuticals has withdrawn plans for its $86 million IPO. The company had filed for the IPO back in August 2015. This is yet another instance of a biotech company withdrawing its IPO, highlighting the challenging environment for capital raising for the sector.

Analyst Ratings

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Aerie Pharmaceuticals (AERI) RBC Capital Markets Price Target Raised Outperform From $51 to $55 N/A
Alimera Sciences (ALIM) Cowen and Company Upgrade From Market Perform to Outperform

$3

N/A
Aralez Pharmaceuticals (ARLZ) Chardan Capital Reiterate Buy

$10

N/A
Biogen (BIIB) Stifel Nicolaus Reiterate Hold N/A

$420

Biogen (BIIB) JPMorgan Chase & Co. Reiterate Buy

$387

$420

Celgene (CELG) Bank of America Reiterate Buy

$128

$140

Depomed (DEPO) Mizuho Reiterate Buy

$23

$30

Endo International Plc (ENDP) Citigroup Price Target Cut Buy From $40 to $25 N/A
Gemphire Therapeutics (GEMP) RBC Capital Markets Reiterate Outperform

$25

N/A
GlaxoSmithKline (GSK) JPMorgan Chase & Co. Reiterate Neutral N/A N/A
GlaxoSmithKline (GSK) Beaufort Securities Reiterate Buy N/A N/A
Halozyme Therapeutics (HALO) Piper Jaffray Cos. Price Target Raised Overweight From $15 to $18 N/A
Intercept Pharmaceuticals (ICPT) Wedbush Reiterate Outperform

$239

N/A
Mallinckrodt (MNK) Leerink Swann Price Target Raised Outperform From $91 to $92 N/A
Novavax (NVAX) Wedbush Downgrade From Outperform to Neutral From $14 to $2 N/A
Novavax (NVAX) FBR & Co. Price Target Cut Outperform From $17 to $12 N/A
Novavax (NVAX) Ladenburg Thalmann Downgrade From Buy to Neutral N/A N/A
Novavax (NVAX) Piper Jaffray Cos. Downgrade From Overweight to Neutral N/A N/A
Novavax (NVAX) JPMorgan Chase & Co. Downgrade From Overweight to Neutral N/A N/A
Novavax (NVAX) Citigroup Downgrade From Buy to Neutral From $12 to $1.50 N/A
Novavax (NVAX) S&P Equity Research Price Target Cut N/A From $1.44 to $1.17 N/A
Recro Pharma (REPH) Roth Capital Initiation Buy

$24

N/A
Rigel Pharmaceuticals (RIGL) Jefferies Group Price Target Raised Positive From $8.50 to $9 N/A
Raptor Pharmaceuticals (RPTP) Cowen and Company Downgrade From Outperform to Market Perform

$9

N/A
Seattle Genetics (SGEN) Goldman Sachs Group Downgrade From Neutral to Sell N/A N/A
Seattle Genetics (SGEN) Leerink Swann Reiterate Buy

$62

N/A
Synergy Pharmaceuticals (SGYP) BTIG Research Reiterate Buy N/A

$13.50

Summit Therapeutics (SMMT) HC Wainwright Initiation Buy

$26

N/A
Xoma Corp. (XOMA) Wedbush Price Target Raised Outperform From $1.42 to $3 N/A
Company Analysts Rating From To
C.R. Bard (NYSE: BCR) Wells Fargo Upgraded Market Perform Outperform
DexCom (NASDAQ: DXCM) Desjardins Upgraded Hold Buy
DexCom BTIG Research Downgraded Buy Neutral
Alimera Sciences (NASDAQ: ALIM) Cowen & Company Upgraded Market Perform Outperform
Seattle Genetics (NASDAQ: SGEN) Goldman Sachs Upgraded Sell Neutral
Akorn Piper Jaffray Upgraded Neutral Overweight
Community Health Systems (NYSE: CYH) Susquehanna Upgraded Neutral Positive
AstraZeneca (NYSE: AZN) Jefferies Upgraded Hold Buy
McKesson (NYSE: MCK) Goldman Sachs Downgraded Buy Neutral
Cardinal Health (NYSE: CAH) Goldman Sachs Downgraded Buy Neutral
Novavax (NASDAQ: NVAX) Wedbush Downgraded Outperform Neutral
Raptor Pharmaceutical (NASDAQ: RPTP) Cowen & Company Downgraded Outperform Market Perform
Vitae Pharmaceuticals (NASDAQ: VTAE) BMO Capital Downgraded Outperform Market Perform
Atara Biotherapeutics (NASDAQ: ATRA) Goldman Sachs
Downgraded Neutral Sell
GlaxoSmithKline (NYSE: GSK) BNP Paribas Downgraded Neutral Underperform