On December 20, 2019 AstraZeneca reported that it has agreed to sell the commercial rights to Arimidex (anastrozole) and Casodex (bicalutamide) in a number of European, African and other countries1 to Juvisé Pharmaceuticals (Press release, AstraZeneca, DEC 20, 2019, View Source [SID1234552541]).

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The medicines, used primarily to treat breast and prostate cancers, have lost their compound patent protection in these countries. AstraZeneca already divested the rights to both Arimidex and Casodex in the US in 2017.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Arimidex and Casodex are important established medicines and we are pleased that Juvisé Pharmaceuticals will now take on the work of making sure patients continue to have access to them. Today’s agreement is part of a broader strategy of reducing our portfolio of mature medicines to reallocate resources towards developing our pipeline of new medicines."

Financial considerations

As there were no closing conditions to the divestment, the agreement became effective upon signing. Juvisé Pharmaceuticals has made an upfront payment of $181m to AstraZeneca and may also make future sales-contingent payments of up to $17m. Income arising from the upfront payment will be reported in AstraZeneca’s financial statements in the fourth quarter of 2019. Income from the upfront and any future payments will be reported within Other Operating Income & Expense. In 2018, Arimidex had sales of $37m in the countries covered by this agreement, while Casodex had sales of $24m. The divestment does not change the Company’s financial guidance for 2019.

About Arimidex

Arimidex (anastrozole) is an aromatase inhibitor, indicated primarily for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and the treatment of advanced breast cancer in postmenopausal women with disease progression, following tamoxifen therapy.

About Casodex

Casodex (bicalutamide) is an androgen-receptor inhibitor, indicated for use in combination therapy with a luteinising hormone-releasing hormone analogue for the treatment of Stage D2 metastatic carcinoma of the prostate.

On December 20, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported the pricing of its public offering of 26,982,945 shares of its common stock at a public offering price of $2.50 per share and in lieu of common stock, pre-funded warrants to purchase 9,017,055 shares of its common stock at a purchase price of $2.4999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant (Press release, Abeona Therapeutics, DEC 20, 2019, View Source [SID1234552576]). The aggregate gross proceeds from the offering are expected to be $90 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Abeona. All of the shares of common stock and pre-funded warrants are being offered by Abeona. In addition, Abeona has granted the underwriters a 30-day option to purchase up to an additional 5,400,000 shares of its common stock from Abeona at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on December 24, 2019, subject to the satisfaction of customary closing conditions.

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An existing holder of the Company’s common stock, Great Point Partners ("GPP"), has agreed to purchase approximately $31 million in the offering, including pre-funded warrants in lieu of common stock, subject to allocation by the underwriters and market and other conditions. The Company has granted GPP the right to nominate two directors, including a new Executive Chairman, to Abeona’s Board of Directors. GPP has indicated that it expects such director nominees would be industry professionals not affiliated with GPP. As a result, Steven H. Rouhandeh will step down as Executive Chairman and will retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne will exit the Board. These changes will be effective upon the Board’s qualification and election of GPP’s nominees.

Jefferies LLC and SVB Leerink LLC are acting as book-running managers and underwriters for the offering.

Abeona intends to use the net proceeds of the offering to fund continued clinical development of pipeline products, as well as for working capital and corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224867) that was filed with the Securities and Exchange Commission (the "SEC") on May 11, 2018 and amended on June 1, 2018, and that was declared effective by the SEC on June 7, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus that form a part of the registration statement has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, via telephone at (877) 821-7388, or email at: [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

On December 20, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported that it has entered into a definitive agreement for a private placement with institutional investors to purchase an aggregate of 9,569,430 shares of common stock and, in lieu of shares of common stock, pre-funded warrants to purchase an aggregate of 5,780,537 shares of common stock, and accompanying warrants (the "Milestone Warrants") to purchase an aggregate of up to 32,577,209 additional shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) at a price of $1.745 per share and accompanying Milestone Warrant (or $1.744 per pre-funded warrant and accompanying Milestone Warrant) (Press release, Savara, DEC 20, 2019, View Source [SID1234552559]). The price per pre-funded warrant and accompanying Milestone Warrant represents the price of $1.745 per share and accompanying Milestone Warrant to be sold in the private placement, minus the $0.001 per share exercise price of each such pre-funded warrant. The exercise price of the Milestone Warrants is $1.48 per share, or if exercised for a pre-funded warrant in lieu thereof, $1.479 per pre-funded warrant (representing the Milestone Warrant exercise price of $1.48 per share minus the $0.001 per share exercise price of each such pre-funded warrant). The Milestone Warrants are exercisable at any time prior to the earlier of 30 days following the achievement of a defined clinical milestone or two years after the closing date of the private placement. The gross proceeds from the sales of common stock and pre-funded warrants are expected to be $26.8 million, before deducting placement agent fees and estimated offering expenses payable by Savara. If the Milestone Warrants are exercised in full, Savara would receive additional gross proceeds of $48.2 million, resulting in total transaction gross proceeds of $75.0 million, in each case before deducting placement agent fees and estimated offering expenses payable by Savara. The private placement, led by Bain Capital Life Sciences, with participation by certain existing and new investors, including EcoR1 Capital LLC and Logos Capital, is expected to close on December 24, 2019, subject to customary closing conditions. In connection with the closing, Ricky Sun, Ph.D. of Bain Capital Life Sciences is expected to join the Savara board of directors.

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Net proceeds from the transaction are expected to be used to fund a new clinical trial of Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) and for other general corporate purposes.

Jefferies and Evercore ISI are acting as placement agents to the Company in connection with the private placement.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants and Milestone Warrants no later than 120 days after the closing of the private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On December 20, 2019 Kyowa Kirin Co., Ltd. (TSE: 4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that it has received the partial change approval for ORKEDIA (code name: KHK7580, generic name: evocalcet)*1 for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy*2 from the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Kyowa Hakko Kirin, DEC 20, 2019, View Source [SID1234552543]).

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The approval is based on the result of the Phase 3 clinical trial that evaluates the efficacy of ORKEDIA for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

ORKEDIA was also granted Orphan Drug Designation for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy by the MHLW on March 4, 2019.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. *1.

About ORKEDIA (evocalcet)
ORKEDIA is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Kirin signed a license agreement of ORKEDIA with Mitsubishi Tanabe Pharma for the rights of cooperative research, develop, market and manufacture of the product in Japan and some parts of Asia in March 2008. In March 2018, Kyowa Kirin received approval of ORKEDIA for secondary hyperparathyroidism in maintenance dialysis patients and later in May 2018, the product was launched in Japan market, named ORKEDIA Tablets. *

2. About Hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy

Parathyroid carcinoma and primary hyperparathyroidism (PHPT) are diseases in which serum calcium levels are elevated due to over autonomous secretion of parathyroid hormone (PTH) from tumors of the parathyroid gland. Parathyroidectomy (PTx) is the only reliable method to treat parathyroid carcinoma and PHPT. Control of hypercalcemia can prove challenging in cases of PHPT where PTx cannot be considered because of concomitant diseases or where PHPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. Hypercalcemia causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis

On December 20, 2019 Johnson & Johnson reported the acquisition of TARIS Biomedical LLC (TARIS), a privately-owned biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer (Press release, Johnson & Johnson, DEC 20, 2019, View Source;johnson-acquires-taris-biomedical-with-focus-on-transforming-the-treatment-of-bladder-cancer-300978469.html [SID1234552560]). The company’s lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. Financial terms of the transaction are not being disclosed.

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"The TARIS technology provides a first-in-class clinical stage platform to evaluate novel, locally-delivered therapeutics for patients with localized bladder cancer," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "Together with the TARIS team, we look forward to advancing complete regimens to push towards early interception of bladder cancer with the goal of improving outcomes for patients and, ultimately, delivering cures."

Localized bladder cancer is a global unmet need as reflected by high morbidity and limited improvements in treatment over the past two decades. Globally, bladder cancer is the sixth most commonly occurring cancer in men and the 17th most commonly occurring cancer in women.1 There were almost 550,000 new cases of bladder cancer diagnosed worldwide in 2018.1 The majority of bladder cancers are diagnosed in the early stages with approximately 70 to 75 percent as non-muscle invasive bladder cancer and 25 to 30 percent as muscle invasive bladder cancer.2,3 Progression of the disease is a devastating life-changing event that can result in removal of the bladder in patients fit for surgery.4 Following surgery, and for a large proportion of patients who are unfit for such a procedure, the cancer often progresses into metastatic disease where the five-year survival rate is approximately five percent.5 Considering the global impact and need for new, targeted therapies, Janssen is building upon its innovative efforts and disease expertise to advance novel, locally-delivered therapeutic approaches with a strategy to intercept bladder cancer.

"The TARIS technology and scientific team create an unparalleled convergence opportunity with real potential to deliver differentiated, targeted therapeutics for the treatment of patients with localized bladder cancer," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen R&D, Johnson & Johnson. "We are eager to build upon the proof-of-concept data that the TARIS team has generated and advance clinical development of this drug delivery approach for patients who face a bladder cancer diagnosis, and potentially for other types of cancer in the future."

TARIS will maintain a research presence in Lexington, Massachusetts and become part of Janssen R&D’s Oncology Therapeutic Area. The team will remain focused on the optimization of drug candidates working together with Janssen R&D scientists to advance and deliver future clinical programs applying the TARIS technology, which arose from research conducted at MIT’s Koch Institute for Integrative Cancer Research.