On April 16, 2019 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that Axumin (fluciclovine (18F)) has recently been added to the European Association of Urology (EAU) 2019 Clinical Practice Guidelines in Oncology for Prostate Cancer (PCa) (Press release, Blue Earth Diagnostics, APR 16, 2019, View Source [SID1234535148]). The EAU PCa Guidelines assist clinicians in making informed decisions, taking into consideration the scientific data available and individual circumstances of patients. These updated EAU PCa Guidelines state that "18F – Fluciclovine has been approved in the US and Europe, and therefore is currently the only PCa-specific radiotracer widely commercially available."

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Axumin is the first and only novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize recurrent prostate cancer. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics said "We are delighted that Axumin has been included in the EAU Guidelines as it is an important recognition of the clinical value of our product. Inclusion in these guidelines can help facilitate increased access, in concurrence with our commitment to maximize access to Axumin to patients and clinicians in Europe."

Prostate cancer is a leading cause of cancer death in men in Europe, with around 450,000 new cases diagnosed each year1.

The European Association of Urology (EAU) is the leading authority within Europe on urological practice, research and education, with a mission to raise the level of urological care throughout Europe and beyond.

On April 16, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 629 million in the first quarter of 2019 (Press release, Genmab, APR 16, 2019, View Source [SID1234535147]). Net sales were USD 352 million in the U.S. and USD 277 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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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.1 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. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. 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).1,2,3,4,5

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 April 15, 2019 Aqilion reported that searches for early innovative pharmaceutical projects thatare based on solid research resting on a firm biological foundation and offering both clinical relevance and patient benefit (Press release, Aqilion, APR 15, 2019, View Source [SID1234568119]). Immunscape has developed innovative molecules that could potentially become new drugs for the treatment of cancer and autoimmune diseases. The project is currently in an early phase of development. The purpose of the new collaboration is to jointly assess and develop the commercial potential of the project.

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Aqilion can invest resources in interesting projects to further evaluate their potential and to ensure that they proceed to a full-scale project or project company. Both Aqilion and Immunscape are actively engaged in the assessment in a collaboration that entails an exclusive option for Aqilion to continue its involvement if the project proves to be promising.

"The pre-project phase is important to strengthen the common vision of the project and to assess together with Immunscape’s team whether Aqilion is the right partner to promote continued commercial development of the project. Immunscape has solid drug discovery experience and expertise and the company’s innovative molecule platform is extremely interesting for Aqilion. We look forward to working together on this exciting project," says Sarah Fredriksson, CEO of AQILION AB.

"We are extremely pleased to have initiated this collaboration with Aqilion, which will accelerate our drug discovery efforts," says Lars Öhman, CEO of Immunscape AB.

On April 15, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the closing of its previously announced underwritten public offering in the United States of 4,830,000 American Depositary Shares ("ADSs") representing 4,830,000 ordinary shares, at a public offering price of $24.00 per ADS, which includes an additional 630,000 ADSs issued upon the exercise in full of the underwriters’ option to purchase additional ADSs (Press release, Autolus, APR 15, 2019, View Source [SID1234550820]). Aggregate net proceeds to Autolus, after underwriting discounts but before estimated offering expenses, were $109.0 million. All of the ADSs were offered by Autolus.

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Goldman Sachs & Co. LLC and Jefferies LLC acted as joint book-running managers for the offering. Wells Fargo Securities, LLC and William Blair & Company, L.L.C. acted as lead managers.

The offering was made only by means of a prospectus. The final prospectus related to the offering was filed with the U.S. Securities and Exchange Commission (the "SEC"). Copies of the final prospectus can be obtained from either of the joint book-running managers for the offering, Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at +1 866 471 2526 or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at + 1 877 821 7388 or by email at [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant EU member state) and will not have been reviewed by any competent authority in any EU member state.

A registration statement on Form F-1 relating to these securities was declared effective by the SEC on April 10, 2019. The registration statement can be accessed through the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On April 15, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal, and splenic MZL (Press release, TG Therapeutics, APR 15, 2019, View Source [SID1234535144]).

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Umbralisib monotherapy is being evaluated in the UNITY-NHL Phase 2b registration directed clinical trial. The MZL cohort of the UNITY-NHL trial is currently evaluating the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen, the same indication for which the FDA recently granted breakthrough therapy designation for umbralisib.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated "Receiving orphan drug designation for umbralisib in patients with MZL is another important milestone in our commitment to developing novel treatment options for patients with B-cell malignancies, including orphan diseases such as MZL." Mr. Weiss continued, "We are highly encouraged by the interim results presented thus far for the MZL cohort of the UNITY-NHL trial and we look forward to presenting final data from this cohort later this year and to discussing the results with the FDA with the goal of filing for accelerated approval of umbralisib by year-end."

ABOUT ORPHAN DRUG DESIGNATION

Orphan drug designation is granted by the U.S. FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

ABOUT MARGINAL ZONE LYMPHOMA

Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients, MZL is the third most common B-cell NHL accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL, nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).

ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort

The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by Independent Review Committee (IRC) assessment. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

The MZL cohort completed enrollment in August 2018, and in February of 2019 the Company announced that the primary endpoint of ORR as determined by central IRC was met for all treated patients (n=69).

Earlier this month at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, interim data from the UNITY-NHL MZL cohort were presented on the first 42 patients enrolled, demonstrating an ORR of 52%, with a Complete Response (CR) rate of 19%, and a tolerable safety profile amongst all patients treated to date (n=69).