On January 22, 2019 Selecta Biosciences, Inc. (Nasdaq: SELB) ("Selecta"), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR (SVP Rapamycin), reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Selecta Biosciences, JAN 22, 2019, View Source [SID1234532826]). Selecta expects to grant the underwriters a 30-day option to purchase an additional 15% of the shares of its common stock offered in the offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Stifel is acting as book-running manager for the offering. Canaccord Genuity and Needham & Company are acting as co-lead managers, and Janney Montgomery Scott is acting as co-manager for the offering.

Selecta intends to use the net proceeds from the offering, in addition to its existing cash resources, to advance the clinical development of SEL-212, including the completion of a head-to-head superiority trial of SEL-212 compared to the current FDA-approved uricase therapy, completion of the Phase 2 clinical trial and preparations for a Phase 3 clinical trial, for other pre-clinical programs, including gene therapy development work, and for other operational activities and general corporate purposes.

The securities described will be offered by Selecta pursuant to a shelf registration statement on Form S-3 (No. 333-219900), including a base prospectus, which was declared effective by the Securities and Exchange Commission ("SEC") on August 28, 2017. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from: Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

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 sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 22, 2019 Klaria AB (Klaria) (Parent Company, Klaria Pharma Holding AB, Stockholm OMX Nasdaq:KLAR) and Purdue Pharma (Canada) reported they have entered into an exclusive development agreement for KL-01401 (Epinephrine Oromucosal Film) (Press release, Purdue Pharma, JAN 22, 2019, View Source;license-and-supply-agreements-with-purdue-pharma–canada–for-th,c2724247 [SID1234553985]). KL-01401 is a developmental stage formulation of epinephrine for emergency treatment of severe anaphylactic reactions in patients who are at increased risk for anaphylaxis. KL-01401 will be co-developed by Klaria and Purdue Pharma (Canada). The development agreement includes exclusive global license and supply options for the independently associated Purdue/Napp/Mundipharma network of companies upon achievement of defined milestones.

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Under the terms of the agreement, the total value of all milestones achievable is 55.2 million US Dollars. In addition, Klaria will receive mid-to-upper single digit royalties on net sales. Further terms of the agreements give Klaria exclusive manufacturing rights to supply the global market with KL-01401.

In order to complete the agreement with Purdue, Klaria AB has also added epinephrine to its license agreement with Uppsalagruppen Medical AB. In the agreement between Klaria and Uppsalagruppen, Uppsalagruppen will receive a four precent royalty on Klaria’s net income from sales of KL-01401.

KL-01401 is based on Klaria’s novel patented drug delivery platform, which provides several benefits to patients who may require emergency treatment, for anaphylactic reactions. It is planned as an easy to use, non-injectable self-administered treatment that allows patients and their caregivers to discreetly carry a life-saving emergency treatment medication with them at all times.

Dr. Scott Boyer, CEO, Klaria commented: "We are extremely pleased and encouraged to enter into this agreement with Purdue – our second collaboration to date. This agreement combines the strengths of our patented drug delivery platform with a partner who is a leader in development and commercialization of innovative treatments. We are confident that the result of our partnership will meet an unmet medical need for patients relying on epinephrine in the event of a severe allergic reaction."

David Pidduck, President and CEO of Purdue Pharma (Canada) commented:"Today’s agreement signals an exciting move for Purdue as we endeavour to shift the treatment paradigm for Canadians living with the threat of an anaphylactic reaction. Anaphylaxis is the most serious type of allergic reaction and current treatment options continue to face increasing challenges, including availability. The deepening of our partnership with Klaria by entering into a second development agreement with them is another example of our commitment to investing in new technologies and treatment options that will make a positive impact on the healthcare system and on patients’ lives. This agreement is consistent with our overall strategy of expanding opportunities through business development."

On January 22, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 2,025 million in 2018 (Press release, Genmab, JAN 22, 2019, View Source [SID1234532812]). Net sales were USD 1,203 million in the U.S. and net sales in the rest of the world were USD 822 million. Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX. Worldwide net sales of DARZALEX in 2017 were USD 1,242 million, resulting in royalty income of DKK 1,013 million to Genmab

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On January 22, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its licensing partner, Janssen Biotech, Inc. (Janssen), reported that it has submitted the first part of a regulatory submission to the U.S. Food and Drug Administration (U.S. FDA) for a label expansion to include the use of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant (ASCT) (Press release, Genmab, JAN 22, 2019, View Source [SID1234532813]). The U.S. FDA plans to review this application under their Real-Time Oncology Review (RTOR) pilot program. Inclusion in the RTOR pilot program does not guarantee or increase the probability of approval of this supplemental Biologics License Application (sBLA). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"We are encouraged that the submission for daratumumab in combination with lenalidomide and dexamethasone has begun, with a potential for the regimen to be approved earlier for US patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The submission package is based on data from the Phase III MAIA (MMY3008) study of daratumumab in combination with lenalidomide and dexamethasone as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT.

About the RTOR Pilot Program
The aim of the RTOR pilot program is to explore a more efficient review process for supplemental New Drug Applications (sNDAs) and sBLAs to provide safe and effective treatments to patients as early as possible. More information is available on the U.S. FDA website: View Source

About the MAIA (MMY3008) study
The Phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT. Patients were randomized to receive either daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. In the daratumumab treatment arm, patients received 16 milligrams per kilogram (mg/kg) weekly for first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide was administered at 25 mg orally on days 1 through 21 of each 28-day cycle, and dexamethasone was administered at 40 mg once a week for both treatment arms. Participants in both treatment arms will continue treatment with lenalidomide and dexamethasone until disease progression or unacceptable toxicity. The primary endpoint of the study is progression free survival.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 30,770 new patients are expected to be diagnosed with multiple myeloma and approximately 12,770 people are expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 124,225 people would be diagnosed and 87,084 would die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On January 22, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the closing of its previously announced underwritten public offering of 1,854,838 shares of its common stock at a public offering price of $62.00 per share (Press release, Mirati, JAN 22, 2019, View Source [SID1234532814]). This includes the exercise in full by the underwriters of their option to purchase up to 241,935 additional shares of common stock. The aggregate gross proceeds to Mirati from this offering were approximately $115.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati.

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J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC acted as joint book-running managers in the offering.

The shares of common stock described above were offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from 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; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

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 sale of these securities in any state or other jurisdiction in 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.