Seagen (SGEN) to be acquired by Merck (MRK)?

 The Wall Street Journal reported the $40 billion deal for Seagen Inc. is unlikely to be finalized ahead of the pharmaceutical giant’s earnings later this month, though the talks remain on track, according to people familiar with the matter.

• Seagen helped pioneer a class of drugs known as antibody drug conjugates. The therapies take advantage of the honing abilities of antibody drugs to deliver a potent toxin to a specific tumor target.
• As soon as this month, a study evaluating Seagen’s Padcev as a first-line treatment for bladder cancer could produce data. The study is examining Padcev’s use alone and in combination with Keytruda, according to analysts.
• Longtime CEO Clay Siegall, who co-founded the company more than 24 years ago, resigned in May in the wake of allegations of domestic abuse.
  

Oct 8, 2020 :  Seattle Genetics shortened its name to Seagen, dropping local connection as it goes global. The name reflects the company's growth over 23 years from a Seattle-based biotech to an organization with three cancer fighting drugs on the market.

  

May 16, 2022 — Clay Siegall spent 33 hours in jail and was charged with fourth degree misdemeanor assault. 

Seagen CEO and co-founder Clay Siegall, 61, built the Seattle-area biotech into one of the most successful in the world.   A proxy filing also revealed Siegall to be one of the highest-paid executives in the industry, making $18.9 million in 2021.

 

Seagen has gained FDA approvals for four of its cancer treatments. Last year, the company reported $1.6 billion in revenue.
 

Siegall has been the company’s CEO since he co-founded the company, then called Seattle Genetics, in 1998. The company’s first oncology drug, Adcetris, was approved in 2011, and it now has four commercial products and employs 2,800 people in the Seattle area, Canada, Switzerland, and Europe. New plans are also in place to build a 270,000 square foot manufacturing facility north of Seattle. Seagen’s market value is $20 billion and it reported $1.6 billion in revenue last year.

 

Siegall, 61, is alleged to have pushed his 46-year-old wife, Nellie, to the floor and dragged her causing bruises and abrasions.

 

 Clay and Nellie Siegall

• April 23, 2022 : Clay Siegall is arrested and taken to jail in Snohomish County, Washington.
• Seagen CEO's arrest came during a hazy night of booze, sex and alleged violence
• When police arrived at the home sometime near 4 a.m., Nellie Siegall, Siegall’s wife of nearly three years, was at the front door naked and intoxicated, according to the report, with abrasions on her forehead and knees. Clay Siegall was described as “intoxicated” and “assaultive” as he denied the abuse.
• A summary of jail calls between Siegall and his wife shows that a day after the arrest, Siegall “thanked her for the possibility that he may get fired and that she may have ruined his career.” Siegall was released on April 24.
  
• April 28: Clay Siegall filed for divorce from his wife, Nellie.
• May 15: Seagen CEO and co-founder Clay Siegall resigned from Seagen.  Seagen has named its chief medical officer, Roger Dansey, M.D., to take over as interim CEO.
  

-=Seattle Genetics (SGEN) soars on positive trial of breast cancer treatment

• The biotech company added a drug called tucatinib to a regimen using Roche's Herceptin and a generic medicine known as capecitabine. Using all three drugs improved outcomes in patients with breast cancer, including those whose cancer spread to the brain.
• Patients who received the regimen were 46% less likely to worsen than those who took just Herceptin and capecitabine. The tucatinib regimen also improved overall survival by 34% compared with the combination of Herceptin and capecitabine alone.
• Notably, the three-drug regimen showed promise in patients whose cancer had spread to the brain. Adding tucatinib to Herceptin and capecitabine reduced the risk of disease progression or death by 52% in these patients vs. those on the two-drug breast cancer treatment.

Seattle Genetics Inc. announced positive results in a trial of a treatment for breast cancer.
Bothell, Wash.-based Seattle Genetics said the trial of tucatinib in locally advanced or metastatic HER2-positive breast cancer met its primary endpoint of progression-free survival. Patients were treated with tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone. The trial also met its secondary endpoints.

"Based on these findings, we plan to unblind the trial and offer tucatinib to patients on the control arm," Chief Medical Officer Roger Dansey said in a statement. The company is also planning to submit a New Drug Application to the FDA in the first quarter of 2020, he said. HER2-positive breast cancer is an aggressive form of the disease that affects 15% to 20% of cases worldwide. The trial is expected to enroll about 460 patients in North America, Europe and Asia. Leerink analysts said the trial is another win for Seattle Genetics and a "near best-case scenario."

=Incyte (INCY) and Merck (MRK) : failed key Phase 3 melanoma study

• Biotech stocks (XBI) lower after important immune-oncology combo data (Incyte's IDO inhibitor plus Merck's Keytruda) fails in key Phase 3 melanoma study:  NLNK (IDO inhibitor peer) -37.57%,  INCY -18.23%,  NKTR -9.84%,  JNCE -10.20%,  LABU -5.14%,  FPRX -3.84%,  ONCS -3.72%,  SAGE -2.21%,  SGEN -1.81%,  BLUE -4.85%,  PBYI-1.85%,  SPPI -2.46%,  CRVS -9.17%,  TSRO +0.37%,  BMRN -2.01%, GLYC-2.03%, MRK-1.19% 
• IBB -1.99%,  XBI -1.78%

Incyte announces that the External Data Monitoring Committee determined that the Phase 3 ECHO-301/KEYNOTE-252 study did not meet the primary endpoint 

The co and Merck (MRK) announced that an external Data Monitoring Committee review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte's epacadostat in combination with Merck's KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.

• The study's second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.

Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

=Cascadian Therapeutics (CASC) to be acquired by Seattle Genetics (SGEN) for $10.00/share

Cascadian Therapeutics to be acquired by Seattle Genetics (SGEN) for $10.00/share in cash, or approximately $614 mln; SGEN issues prelim Q4 results

Cascadian Therapeutics' most advanced program is tucatinib, an investigational oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal, ovarian and gastric. Tucatinib is currently being evaluated in a randomized global pivotal trial called HER2CLIMB for patients with HER2-positive (HER2+) metastatic breast cancer, including patients with or without brain metastases.

• The transaction is anticipated to close in the first quarter of 2018. In connection with the transaction, Seattle Genetics has secured a financing commitment in the amount of $400 million from Barclays and JPMorgan-Chase Bank. The balance of the consideration will be provided from cash on hand.
• Prelim Q4 results: Seattle Genetics sees Q4 revs of $128-130 mln vs $114.20 mln Capital IQ Consensus Estimate
  • Total revenues increased from the comparable periods in 2016 primarily as a result of increased ADCETRIS net product sales. ADCETRIS net product sales increased from the comparable periods in 2016 primarily due to an increase in sales volume and, to a lesser extent, price increases. The increases in sales volumes in both periods were driven primarily by increased use of ADCETRIS across multiple lines of therapy in Hodgkin lymphoma and for the treatment of other malignancies.

Seattle Genetics announces proposed offering of $550 mln of common stock
Seattle Genetics anticipates using the net proceeds from the offering to fund a portion of the costs of the acquisition of Cascadian Therapeutics, Inc. In the event that Seattle Genetics does not consummate such acquisition, Seattle Genetics expects to use the net proceeds from the offering for the ongoing commercialization of ADCETRIS (brentuximab vedotin) in the United States and Canada, its research and development efforts designed to further expand the ADCETRIS label and the advancement of its pipeline of product candidates, as well as for general corporate purposes, including working capital.

=Seattle Genetics (SGEN) reported earnings on Thur 26 Oct 2017 (a/h)

Seattle Genetics beats by $0.74, beats on revs

• Reports Q3 (Sep) earnings of $0.34 per share, $0.74 better than the Capital IQ Consensus of ($0.40); revenues rose 27.3% year/year to $135.29 mln vs the $112.76 mln Capital IQ Consensus.
  • Due to the gain on the Immunomedics warrant, Seattle Genetics reported net income in the third quarter of 2017 of $50.0 million, or $0.34 per fully diluted share, compared to a net loss of $31.8 million, or $0.23 per share, for the third quarter of 2016.
  • As part of a previously terminated license transaction with Immunomedics, Seattle Genetics holds 3.0 million shares of Immunomedics common stock and a warrant to purchase an additional 8.7 million shares. In September 2017, Immunomedics' resale registration statement covering the shares issuable upon exercise of the warrant was declared effective by the SEC. As a result, the warrant is accounted for as a derivative security and marked-to-market. This led to a gain of $78.7 million reflected in investment and other income, net, recorded in the quarter ended September 30, 2017.
• 2017 Outlook
  • Revenues from collaboration and license agreements $90 million -$100 million (prior: $75-90 million)
  • Royalty revenues $60 million to $65 million (prior: $50-55 million)
  • Research and development expenses (prior: $460-480 million)
• "We have recently delivered on several important goals that continue to strengthen the ADCETRIS brand and advance our portfolio of pipeline programs. The FDA granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma based on data from the phase 3 ECHELON-1 clinical trial, and we are on track to submit a supplemental Biologics License Application (BLA) for this indication soon. And, the supplemental BLA for ADCETRIS in cutaneous T-cell lymphoma was filed by the FDA with priority review and a PDUFA date of December 16, 2017," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We have also made significant progress with our pipeline, which now includes two ADCs for which we are pursuing rapid development pathways based on positive FDA feedback. We and our partner Astellas have initiated a pivotal phase 2 trial of enfortumab vedotin in metastatic urothelial cancer, and we and our partner Genmab plan to advance tisotumab vedotin into a pivotal phase 2 trial for recurrent or metastatic cervical cancer in the first half of 2018. We anticipate several additional milestones before the end of 2017, including a strong presence at the American Society of Hematology annual meeting in December highlighted by a presentation of our full ECHELON-1 data in frontline Hodgkin lymphoma." 

Seattle Genetics (SGEN), Bristol-Myers Squibb (BMY): Hodgkin lymphoma positive results

Seattle Genetics (SGEN) and Bristol-Myers Squibb (BMY) unveiled strong data for a combination of their drugs Adcetris and Opdivo in classical Hodgkin lymphoma. All signs of cancer disappeared in 63% of patients.

A series of trials for the combination could "potentially provide a chemotherapy-free treatment option" for patients whose Hodgkin lymphoma either relapsed or can't be treated with surgery.

  

Immunomedics (IMMU) reported earnings on Thur 9 Feb 2017 (a/h)

** charts after earnings **

 

• Immunomedics reports 2Q loss
• Immunomedics enters into exclusive global licensing agreement with Seattle Genetics (SGEN); agreement provides for potential payments of approximately $2 bln, SGEN to purchase 3 mln shares of IMMU common stock at $4.90/share

MORRIS PLAINS, N.J. (AP) _ Immunomedics Inc. (IMMU) on Thursday reported a loss of $24.4 million in its fiscal second quarter.

On a per-share basis, the Morris Plains, New Jersey-based company said it had a loss of 23 cents. Losses, adjusted for non-recurring costs, were 16 cents per share.

The biopharmaceutical company posted revenue of $384,200 in the period. Its adjusted revenue was $384,000.

In the final minutes of trading on Thursday, the company's shares hit $4.30. A year ago, they were trading at $2.07.

*****

Immunomedics enters into exclusive global licensing agreement with Seattle Genetics (SGEN); agreement provides for potential payments of approximately $2 bln, SGEN to purchase 3 mln shares of IMMU common stock at $4.90/share:

Under the agreement, Seattle Genetics will develop, fund, manufacture and commercialize IMMU-132, Immunomedics' proprietary solid tumor therapy candidate. The agreement also provides that Seattle Genetics will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer and submitting the initial Biologics License Application to the U.S. Food and Drug Administration for accelerated approval. The agreement includes the development of additional indications for IMMU-132, including urothelial cancer, small-cell lung cancer and non-small-cell lung cancer, which are currently in Phase 2 clinical studies, along with other solid tumor indications being studied in ongoing clinical trials.

• The agreement provides for potential payments of approximately $2 billion across multiple indications, plus double-digit tiered royalties on global net sales. Under the terms of the agreement, Immunomedics will receive $250 million in upfront cash payment, plus, among other milestone payments, an additional $50 million (or negotiated economic splits) relating to rights outside the U.S., Canada and the EU. The remainder of the consideration comprises approximately $1.7 billion that is contingent upon achieving certain clinical, development, regulatory and sales milestones, including an anticipated near-term milestone for acceptance of the Biologics License Application (:BLA) by the U.S. Food and Drug Administration for TNBC, additional milestones based on regulatory approval of IMMU-132 for TNBC in the U.S. and other territories, and future development and regulatory milestones for additional indications beyond TNBC. Future royalty payments are tiered double-digit royalties based on global net sales. In addition, Immunomedics will retain the right to elect to co-promote IMMU-132 in the United States by participating in 50% of the sales effort, subject to certain parameters set forth in the agreement.
• Under the terms of the agreement, for a limited period, through February 19, 2017, Immunomedics has the right to continue negotiating with a select number of parties still in the strategic process, and accept a superior proposal. Seattle Genetics has the right to match any superior proposal and if it decides not to match, Immunomedics has the right to accept the superior proposal and terminate the proposed development and license agreement upon payment of a termination fee to Seattle Genetics.
• Concurrent with the transaction, Seattle Genetics is purchasing 3,000,000 shares of common stock, representing an approximately 2.8% stake in Immunomedics, at a per share price of $4.90, which represents a 10% premium to Immunomedics' 15-day trading volume weighted average stock price of $4.45 for the period ending at the close of trading February 9, 2017, the last trading day prior to entering into the global licensing agreement.Seattle Genetics will also be issued a three-year warrant to purchase 8,655,804 shares of common stock at the same price, which shall be exercisable when the Company has sufficient authorized shares of common stock to enable the exercise of the warrant. Seattle Genetics will not be eligible to vote its stake at the upcoming 2016 Annual Meeting of Stockholders.

Immunomedics expects that the transaction will fulfill its liquidity needs such that the Company can fund itself without additional equity raises for the foreseeable future. The companies expect the transaction to close in the first quarter of 2017.

Seattle Genetics' (SGEN) cancer drug put on clinical hold after 4 deaths

Dec 27 (Reuters) - Seattle Genetics Inc said four people had died in trials testing its experimental cancer drug, prompting the U.S. Food and Drug Administration to impose a clinical hold on several early-stage studies.

Six patients with acute myeloid leukemia (AML), a type of blood cancer, have been identified with liver toxicity and four have died, the company said on Tuesday.

  

The company is working with the FDA to identify whether the drug is the cause of the toxicity.

The clinical holds have been initiated to evaluate the potential risk of liver toxicity in patients who were treated with the drug and underwent a stem cell transplant either before or after treatment.

The drug, vadastuximab talirine, has been evaluated in more than 300 patients, and will continue to be tested in ongoing late-stage study in older AML patients, the company said.

The drug is also being tested in patients with myelodysplastic syndrome, another form of blood cancer.

** chart before **

Long trade : SGEN +30% (11/16)

Long trade : SGEN +30% (11/16)

Great trade : SGEN +17% (9/16)

• #3 on Tue 9/6/16, and Wed 9/7/16

  

******

• on Sept 8:

Long trade : SGEN +15% (5/16)

• 5/17:  #26

• One week later: