On February 22, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has launched an offering of $500,000,000 aggregate principal amount of senior secured notes due 2027 (the "Secured Notes") and that Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) ("BHA"), the Company’s wholly owned indirect subsidiary, has launched an offering of $750,000,000 aggregate principal amount of 8.500% senior unsecured notes due 2027 (the "Unsecured Notes" and, together with the Secured Notes, the "Notes") (Press release, Valeant, FEB 22, 2019, View Source [SID1234533598]). The Unsecured Notes will be additional notes and form part of the same series as BHA’s existing 8.500% senior notes due 2027. Bausch Health intends to use the net proceeds from the offerings of the Notes, along with cash on hand, to repurchase $1,250 million aggregate purchase price of outstanding notes pursuant to tender offers announced earlier today, including the Company’s outstanding 5.625% Senior Notes due 2021 (the "5.625% Notes") and up to $550,000,000 aggregate purchase price across the Company’s outstanding 5.50% Senior Notes due 2023 (the "5.50% Notes") and 5.875% Senior Notes due 2023 (the "5.875% Notes" and, together with the 5.625% Notes and the 5.50% Notes, the "Existing Notes") and to pay related fees and expenses. This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

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The Secured Notes will be guaranteed by BHA and each of the Company’s other subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Company’s credit agreement and existing senior secured notes. The Unsecured Notes will be guaranteed by the Company and each of its subsidiaries (other than BHA) that are guarantors under the Company’s credit agreement and existing senior notes. Consummation of the offerings of the Notes is subject to market and other conditions, and there can be no assurance that the Company will be able to successfully complete these transactions on the terms described above, or at all. In addition, neither offering is contingent on the consummation of the other.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On February 22, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $500,000,000 aggregate principal amount of 5.750% senior secured notes due 2027 (the "Secured Notes") and that Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) ("BHA"), the Company’s wholly owned indirect subsidiary, has priced its previously announced offering of 8.500% senior unsecured notes due 2027 (the "Unsecured Notes" and, together with the Secured Notes, the "Notes") (Press release, Valeant, FEB 22, 2019, View Source [SID1234533597]). The aggregate size of the offering of the Unsecured Notes is $1,000,000,000, which reflects an increase of $250,000,000 from the previously announced offering size of $750,000,000. The Unsecured Notes will be additional notes and form part of the same series as BHA’s existing 8.500% senior notes due 2027. The Secured Notes will be sold to investors at a price of 100.00% of the principal amount thereof and the Unsecured Notes will be sold to investors at a price of 103.25% of the principal amount thereof (representing a yield to worst of 7.748%). Bausch Health intends to use the net proceeds from the offerings of the Notes, along with cash on hand, to repurchase $1,500 million aggregate purchase price of outstanding notes pursuant to tender offers announced earlier today and upsized this afternoon, including the Company’s outstanding 5.625% Senior Notes due 2021 (the "5.625% Notes") and up to $800,000,000 aggregate purchase price across the Company’s outstanding 5.50% Senior Notes due 2023 (the "5.50% Notes") and 5.875% Senior Notes due 2023 (the "5.875% Notes" and, together with the 5.625% Notes and the 5.50% Notes, the "Existing Notes"), and to pay related fees and expenses. The Company expects the after-tax impact of these transactions to be neutral to 2019 adjusted net income. This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

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The Secured Notes will be guaranteed by BHA and each of the Company’s other subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Company’s credit agreement and existing senior secured notes. The Unsecured Notes will be guaranteed by the Company and each of its subsidiaries (other than BHA) that are guarantors under the Company’s credit agreement and existing senior notes. Consummation of the offerings of the Notes is subject to various closing conditions, and there can be no assurance that the Company will be able to successfully complete these transactions on the terms described above, or at all. In addition, neither offering is contingent on the consummation of the other.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On February 22, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release fourth quarter and annual financial results after market close on Thursday, March 7th, 2019 (Press release, AcelRx Pharmaceuticals, FEB 22, 2019, View Source [SID1234533592]). AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7, 2019 to discuss the financial results and provide a corporate update.

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Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page.

A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

On February 22, 2019 Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug etoposide toniribate, a novel topoisomerase II inhibitor, for the treatment of relapsed refractory biliary tract cancer (Press release, Imbrium Therapeutics, FEB 22, 2019, View Source [SID1234533590]).

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Also known as cholangiocarcinoma, biliary tract cancer is a rare type of cancer that starts in the bile ducts, a series of thin tubes that move bile from the liver and gallbladder to the small intestine (duodenum) to help digest the fats in food. Biliary tract cancer is the second most common primary hepatobiliary cancer, after hepatocellular cancer. About 8,000 people in the United States are diagnosed with biliary tract cancer each year.1 It most commonly affects people age 65 or older.

"We are pleased that the FDA has granted orphan drug designation for etoposide toniribate as we believe, once approved, it can be an important clinical advance for patients suffering from relapsed refractory biliary tract cancer, a patient population that has limited treatment options," said Paul Medeiros, president of Imbrium Therapeutics. "This designation represents Imbrium’s first milestone in oncology and underscores our commitment to advance the clinical development of oncology chemotherapeutics while actively collaborating to advance treatments across our therapeutic portfolio."

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan drug designation to drugs and biological products that are intended for the treatment of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation is intended to facilitate drug development for rare diseases and may provide certain incentives to drug developers, including seven years of market exclusivity and tax credits for qualified clinical testing.2,3

"While patients with early and locally advanced biliary tract cancer often can be treated successfully with surgery and chemotherapy, no treatments are approved for patients with relapsed or refractory disease who require second-line therapy, and only a few agents are in development," said Craig Landau, MD, president and CEO, Purdue Pharma L.P. "This designation is another step toward the goal of advancing clinical development of etoposide toniribate, in conjunction with Mundipharma EDO, toward potential regulatory approval by the US FDA."

Thomas Mehrling, MD, PhD, CEO of Mundipharma EDO, added, "We are pleased that the FDA has granted orphan drug designation to etoposide toniribate for relapsed refractory biliary tract cancer. As a company, we are focused on developing treatments for rare and difficult-to-treat cancers and getting them to patients as rapidly as possible. We look forward to accelerating the development of etoposide toniribate in conjunction with Imbrium Therapeutics."

Etoposide toniribate has shown encouraging data in Phase 2 trials, and these data were key in securing the ODD.4 The European Medicines Agency (EMA) granted orphan designation to etoposide toniribate on June 4, 2014.5

Imbrium Therapeutics, in collaboration with Mundipharma EDO GmbH, expects to initiate a Phase 3 clinical trial of etoposide toniribate in patients with refractory biliary tract cancer in 2020.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

About Biliary Tract Cancer

Biliary tract cancer can develop in any part of the bile duct system. Among those with distal disease, the five-year survival is 15 percent, and the prognosis is worse for patients with intra-hepatic cancer compared with those with extra-hepatic cancer. Nearly two of three people with biliary tract cancer are age 65 or older at the time of diagnosis, and the average age is 70. Risk factors for biliary tract cancer include advancing age, diabetes, inflammatory bowel disease (ulcerative colitis and Crohn’s disease), bile duct stones, cirrhosis, obesity, alcohol consumption, long-term infection with hepatitis B or C virus, and a family history of cholangiocarcinoma. Surgery and chemotherapy are commonly used for early and locally advanced disease, but no treatments are indicated as second-line therapy. Clinical trials of targeted agents and immunotherapy are underway.6

About Etoposide Toniribate

Etoposide toniribate is a novel chemotherapy agent of the topoisomerase II inhibitor class in clinical development for the treatment of relapsed refractory biliary tract cancer. This small molecule drug is designed to work by metabolizing into its active form through enzymes in the gastrointestinal tract that are particularly active in cancer cells. Activated etoposide binds to and inhibits topoisomerase II, which is often elevated in tumors, resulting in double-strand breaks in tumor DNA. Damage to the tumor DNA induces apoptosis (programmed cell death).

Results of a randomized Phase 2 trial of 23 patients with refractory, metastatic, unresectable biliary tract cancer who had relapsed following treatment with gemcitabine/cisplatin showed a one-year overall survival of 44.4 percent with etoposide toniribate versus 11.3 percent with best supportive care (BSC). Overall, 55.6 percent of patients met the primary endpoint of disease control compared with 20.0 percent who received BSC. The most common drug-related adverse events were leukopenia, neutropenia, thrombocytopenia, anemia, alopecia, fatigue and abdominal pain.

On February 22, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that Sheila Gujrathi, M.D., Chief Executive Officer and Co-Founder, will present at the following upcoming investor conferences (Press release, Gossamer Bio, FEB 22, 2019, View Source [SID1234533589]):

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8th Annual SVB Leerink Healthcare Conference on Wednesday, February 27 at 11:00 a.m. ET.
Barclays Global Healthcare Conference on Wednesday, March 13 at 3:50 p.m. ET.