カテゴリー別アーカイブ: Pharma

Horizon Pharma plc Announces Proposed Public Offering of Ordinary Shares

DUBLIN, IRELAND–(Marketwired – Apr 13, 2015) – Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs, today announced that it is offering to sell 12,000,000 of its ordinary shares in an underwritten public offering. Horizon Pharma plc also expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the ordinary shares in the public offering.

Citigroup, Jefferies LLC, Cowen and Company, LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for this offering.

A registration statement relating to the shares described above was previously filed with and became effective by rule of the Securities and Exchange Commission (“SEC”). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and related prospectus, when available, may be obtained by contacting Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at prospectus@citi.com or by phone at 800-831-9146; Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by email at Prospectus_Department@Jefferies.com; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department or by calling (631) 274-2806; or Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Horizon Pharma plc

Horizon Pharma plc is a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The company markets a portfolio of products in arthritis, inflammation and orphan diseases. The company’s U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), PENNSAID® (diclofenac sodium topical solution) 2% w/w, RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole magnesium). Horizon’s global headquarters are in Dublin, Ireland.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the timing and size of the proposed public offering of ordinary shares by Horizon Pharma plc. These forward-looking statements are based on Horizon Pharma plc’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering. Additional risks and uncertainties relating to the public offering, Horizon Pharma plc and its business can be found under the caption “Risk Factors” and elsewhere in Horizon’s SEC filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2014 and its Current Report on Form 8-K filed with the SEC on April 13, 2015. Forward-looking statements speak only as of the date of this press release, and Horizon Pharma plc undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Additional Information and Where to Find It

This communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of common stock of Hyperion Therapeutics, Inc. (“Hyperion”) or any other securities. On April 9, 2015, Horizon Pharma plc filed a tender offer statement on Schedule TO with the SEC and, on the same date, a Solicitation/ Recommendation Statement on a Schedule 14D-9 was filed with the SEC by Hyperion. The offer to purchase shares of Hyperion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT, AS FILED AND AS IT MAY BE AMENDED FROM TIME TO TIME, AND THE SOLICITATION/ RECOMMENDATION STATEMENT, AS FILED AND AS MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION REGARDING THE TENDER OFFER. Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to Georgeson Inc., the Information Agent for the tender offer, at (866) 856-2826.

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Horizon Pharma plc Announces Proposed Public Offering of Ordinary Shares
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Pharma ETFs Soar on Acquisition Spree – ETF News And Commentary

Like 2014, mergers and acquisitions in the health care space have been witnessing a wining momentum in 2015 as well. After the signing of major pharma deals like the Cubist takeover by Merck and Allergan takeover by generic and specialty drug maker Actavis in Q4, the sector went on seeing the same trend to start 2015.

Last month, Abbvie entered into an agreement to acquire Pharmacyclics for $21 billion. There was yet another deal talk between Canadian drug maker Valeant Pharmaceuticals International and leading U.S. gastrointestinal drug maker Salix Pharmaceuticals. And now talks of yet another pharma deal between Mylan N.V. (MYL) and Perrigo Company plc (PRGO) are doing rounds (read: Pharma ETFs to Soar No Matter Who Wins Salix).

Investors should note that the biotech space has been under pressure since this March. So, reports of the latest acquisition proposal by Mylan on April 8, gave the much-needed boost to this sector.

Mylan has proposed to acquire drug maker Perrigo in a cash-and-stock deal valued at $205 per share. In total, the deal is worth around $29 billion. Mylan expects to derive significant synergies out of this deal. Based on 2014 numbers, pro forma sales of the combined entity were approximately $15.3 billion.

The stock market welcomed the reports with much enthusiasm, pushing not only shares of MYL and PRGO higher but also spreading bullishness into the entire health care sector. Shares of Mylan and Perrigo surged 14.8% and 18.4%, respectively, after the news of the likely deal (read: Biotech ETFs in Focus after a Choppy Week).

The day after, shares of both companies were up about 2.54% and 1.90% on elevated volumes. Investors should note that MYL is presently trading at more than four times the regular volume while Perrigo has made it seven times higher.

ETFs in Focus

The news led to a surge in the broader health care ETFs. Top-notch pharma ETF SPDR S&P Pharmaceuticals ETF (XPH) added over 3.3% following the news while was up over 0.3% the day next. Overall, iShares Nasdaq Biotechnology ETF (IBB) gained almost 3% (see: all the Healthcare ETFs here).

We have detailed the performance of the funds in which MYL and PRGO have decent weight and expect these to be in focus over the coming days given the M&A talks.
MYL has over 3% weights in IBB and iShares U.S. Pharmaceuticals ETF (IHE). IHE was up over 2.5% on the day of announcement. On the other hand, PRGO takes the top holding in Market Vectors Israel ETF (ISRA) wtih   over 14% and has over 3.5% share in IHE. ISRA was up 2.75% in the key trading session while it advanced about 0.9% the next day (read:   Israel ETFs in Focus on Surprise Rate Cut).

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ISHARES NDQ BIO (IBB): ETF Research Reports
 
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Pharma ETFs Soar on Acquisition Spree – ETF News And Commentary
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Horizon Pharma's Actimmune Gets Fast Track Status – Analyst Blog

Horizon Pharma plc HZNP announced that the FDA has granted fast track status to Actimmune for the treatment of Friedreich’s ataxia. Actimmune is already approved in the U.S. for the treatment of patients suffering from two rare diseases – chronic granulomatous disease and severe, malignant osteopetrosis.

Currently, Horizon Pharma is working toward expanding the product’s label in additional indications.

Fast track designation is granted to candidates that are being developed for the treatment of a serious or life-threatening disease or condition and is believed to possess the capability to address unmet medical needs. On receiving this designation, Horizon Pharma may communicate with the FDA frequently throughout the entire development and review process, with the aim of expediting the candidate’s approval. Moreover, the company is also eligible to make a rolling submission of new drug application for the candidate, which will be considered for priority review.

Horizon Pharma intends to commence a randomized, double-blind, multi-center, placebo-controlled phase III study on Actimmune in the second quarter of 2015 for the treatment of Friedreich’s ataxia in patients aged between 10 and 25 years. The primary endpoint for the study will measure the change from baseline in the patients after 26 weeks of treatment with ACTIMMUNE compared to placebo. The study will be conducted in collaboration with the Friedreich’s Ataxia Research Alliance (FARA) and a sub-set of FARA’s Collaborative Clinical Research Network study centers. Actimmune enjoys orphan drug designation in the U.S. for Friedreich’s ataxia.

According to the company, there are no therapies approved by the FDA for the treatment of Friedreich’s ataxia. Given that one in 50,000 people in the U.S. suffer from the disease, there is strong unmet need for drugs in the treatment of Friedreich’s ataxia.

Horizon Pharma carries a Zacks Rank #1 (Strong Buy). Other well-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Incorporated CYTK and Acorda Therapeutics, Inc. ACOR. All these stocks carry the same rank as Horizon Pharma.

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Source Article from http://finance.yahoo.com/news/horizon-pharmas-actimmune-gets-fast-175005268.html
Horizon Pharma's Actimmune Gets Fast Track Status – Analyst Blog
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