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AstraZeneca and Merck & Co., Inc. known as MSD outside of the United States and Canada, announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib) for multiple cancer types. LYNPARZA is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
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Titan Pharmaceuticals, Inc. a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery technology, announced today that it has entered into a venture loan and security agreement with Horizon Technology Finance Corporation, which provides Titan with up to USD10 million of available borrowing capacity.
A first tranche of USD7 million was funded upon execution of the loan agreement. A second tranche of USD3 million will be available to Titan, at its option, through March 31, 2018, subject to the satisfaction of certain revenue and product development milestones, and other borrowing conditions.
The loan agreement has a term of 46 months, with interest only payments through December 31, 2018, followed by equal monthly installments of principal and accrued interest for 30 months thereafter. The initial interest rate is 9.63%, which is based on a floating rate equal to the sum of the one month LIBOR (floor of 1.10%) plus 8.4%. Each loan tranche is also subject to a 5.0% final payment when the principal is paid in full. The loan is senior debt and is secured by all of Titan's assets, with the exception of its intellectual property.
"We believe this transaction balances our capital needs and opportunity to grow the company, and our commitment to minimizing dilution for shareholders to the extent possible," commented Titan President and CEO Sunil Bhonsle. "We were impressed with Horizon's ability to tailor a financing structure that matched Titan's objectives. We expect that our existing cash on hand, combined with the net proceeds from the first tranche of this loan, will be sufficient to fund planned operations into early 2019."
Gerald A. Michaud, President of Horizon, stated, "We are pleased to provide this debt financing to Titan. The company's proprietary long-term drug delivery platform, ProNeura, represents a new standard of chronic disease management utilizing subdermal implants. We look forward to working with Titan as its lead product, Probuphine®, advances in the marketplace and the company continues to develop a growing pipeline of new treatments for select therapeutic markets."
In connection with this transaction, Titan issued to Horizon warrants to purchase an aggregate of 280,612 shares of Titan's common stock. The per share exercise price of these warrants is the lower of USD1.96 or the price per share of any securities that may be issued by the company in an equity financing during the next 18 months. The company also issued the lender a warrant that will only become exercisable upon the funding of the second tranche of the loan, with number of shares and exercise price to be calculated at such time. The company has agreed to file a registration statement with the Securities and Exchange Commission (SEC) within the next 90 days covering the resale of the shares underlying the lender warrants.
Amgen announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.
Verona Pharma plc a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that the first patients have been dosed in a Phase 2b clinical trial evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). Verona Pharma expects to report top-line data from this trial in the second half of 2018.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Desonide Cream, 0.05%, the generic version of Desonide Cream, 0.05% of Perrigo New York Inc.
Axsome Therapeutics, Inc a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-06, a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole being developed for the treatment of osteoarthritis and rheumatoid arthritis. Axsome has received, from the U.S. Food and Drug Administration (FDA), Pre-Investigational New Drug Application (Pre-IND) written guidance on a proposed clinical developmental plan for AXS-06. Based on this guidance, Axsome believes that AXS-06 is Phase 3-ready. AXS-06 is now Axsome’s third product candidate in clinical development and its second differentiated oral, non-opioid product candidate for the management of chronic pain.
A nine-year-old South African child who was diagnosed with HIV infection at one month of age and received anti-HIV treatment during infancy has suppressed the virus without anti-HIV drugs for eight and a half years, scientists reported today at the 9th IAS Conference on HIV Science in Paris. This case appears to be the third reported instance of sustained HIV remission in a child after early, limited anti-HIV treatment.
Gilead Sciences, Inc. announced detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) evaluating the efficacy and safety of a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. The data were presented in two late-breaker sessions [MOAB01 and TUPDB02] at the 9th IAS Conference on HIV Science (IAS 2017) in Paris.
Astrazeneca to launch Osimertinib Tablet 40 mg and 80 mg (Tagrisso™) in India after it received nod from Drug Controller General of India. Also stoke pricing of the company is increased by 3 % followed by this announcement.
Cyclacel Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, announced the closing of an underwritten public offering of units for gross proceeds of USD15.2 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Cyclacel. Existing and new investors participated in the offering.
The offering was comprised of Class A Units, priced at a public offering price of USD2.00 per unit, each unit consisting of one share of common stock and a seven-year warrant (each, a “warrant”) to purchase one share of common stock with an exercise price of USD2.00 per share, and Class B Units, priced at a public offering price of USD1,000 per unit, with each unit comprised of one share of preferred stock, which is convertible into 500 shares of common stock, and a warrant to purchase 500 shares of common stock, also with an exercise price of USD2.00 per share. The conversion price of the preferred stock issued in the transaction as well as the exercise price of the warrants are fixed and do not contain any variable pricing features or any price based anti-dilutive features. The preferred stock issued in this transaction includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and, with certain exceptions, has no voting rights. The securities comprising the units were immediately separable and have been issued separately.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT:LTS), acted as sole book-running manager in connection with the offering.
A total of 3,154,000 shares of common stock, 8,872 shares of preferred stock convertible into 4,436,000 shares of common stock, and total warrants to purchase 7,590,000 shares of common stock were issued in the offering, including the full exercise of the over-allotment option. If exercised in full, the warrants could result in additional net financing proceeds to Cyclacel of USD15.2 million.
The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-218305) and an additional registration statement filed pursuant to Rule 462(b), which was declared effective by the United States Securities and Exchange Commission ("SEC").
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering has been filed by Cyclacel with the SEC. Copies of the final prospectus may be obtained at the SEC’s website at sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.
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