===Nektar Therapeutics (NKTR) sues Eli Lilly (LLY) over autoimmune disease treatment

• Aug 7 (Reuters) - Nektar Therapeutics on Monday sued Eli Lilly, accusing the drugmaker of undermining the prospects for Rezpeg, which Nektar was developing as a treatment for various autoimmune diseases. 

Nektar Therapeutics (NKTR) announced that efficacy data previously generated by Eli Lilly for rezpegaldesleukin (REZPEG) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly

• The new and corrected data highlight the important potential of REZPEG to help patients battling atopic dermatitis (AtD), a chronic skin condition that afflicts nearly 10% of Americans. Specifically, the new and corrected data from the atopic dermatitis study demonstrate that 12 weeks of REZPEG therapy at the highest dose resulted in a mean Eczema Area and Severity Index (EASI) score improvement of 83% with a p-value of 0.002 as compared to placebo and an EASI-75 response rate of 41%.
• REZPEG also provided a more rapid and steep drop in EASI scores immediately after therapy initiation than the previously reported erroneous data indicated. This efficacy benefit was also maintained for 36 weeks without additional treatment after the 12-week induction period.

===Sigilon Therapeutics(SGTX) to be acquired by Lilly (LLY) for $14.92 per share

 

Sigilon Therapeutics: Lilly (LLY) to acquire Sigilon Therapeutics for a purchase price of $14.92 per share in cash + CVR

• Under the terms of the definitive agreement, Lilly will commence a tender offer to acquire all outstanding shares of Sigilon for a purchase price of $14.92 per share in cash (an aggregate of approximately $34.6 million) payable at closing, plus one non-tradeable contingent value right ("CVR") per share that entitles the holder to receive up to an additional $111.64 per share in cash, for a total potential consideration of up to $126.56 per share in cash without interest (an aggregate of up to approximately $309.6 million excluding shares held by Lilly). CVR holders would become entitled to receive the following contingent payments: (i) $4.06 per share in cash, upon first dosing of a specified product in the first human clinical trial; (ii) $26.39 per share in cash, upon first dosing of a specified product in the first human clinical trial for registration purposes; and (iii) $81.19 per share in cash, upon receipt of the first regulatory approval of a specified product. There can be no assurance that any payments will be made with respect to the CVRs.
• The transaction is not subject to any financing condition and is expected to close in the third quarter of 2023, subject to customary closing conditions, including that Lilly owns a majority of the outstanding shares of Sigilon's common stock following the tender offer. Following the successful closing of the tender offer, Lilly will acquire any shares of Sigilon it does not already own through a second-step merger at the same consideration as paid in the tender offer. Sigilon's board of directors unanimously recommends that Sigilon's stockholders tender their shares in the tender offer. Lilly will determine the accounting treatment of this transaction as a business combination or an asset acquisition, including any related acquired in-process research and development charges, according to Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly's financial results and financial guidance.

-=Loxo Oncology (LOXO) to be acquired by Eli Lilly (LLY) for $235/share

Loxo Oncology to be acquired by Eli Lilly (LLY) for $235/share in cash, or approximately $8 bln

The acquisition would be the largest and latest in a series of transactions Lilly has conducted to broaden its cancer treatment efforts with externally sourced opportunities for first-in-class and best-in-class therapies. Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing.

• The tender offer represents a premium of approximately 68 percent to Loxo Oncology's closing stock price on January 4, 2019, the last trading day before the announcement of the transaction.
• This transaction will be reflected in Lilly's financial results and financial guidance according to Generally Accepted Accounting Principles (GAAP). Lilly will provide an update to its 2019 financial guidance, including the expected impact from the acquisition of Loxo Oncology, as part of its fourth-quarter and full-year 2018 financial results announcement on February 13, 2019.

=Eli Lilly's (LLY) diabetes drug shows promise in mid-stage trial

• Peer: NVO

Oct 4 (Reuters) - Eli Lilly and Co said on Thursday data from mid-stage trial of its experimental diabetes drug showed clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes.

Data from the six-month study showed that the drug significantly reduced blood sugar levels by up to 2.4 percent and an average weight reduction of up to 12.7 percent, Lilly said in a statement.

The company said it intends to complete its late-stage study for the drug in late 2021, and is also evaluating the drug for treating obesity, among other conditions.

About 30 million adults in the United States have diabetes, with 90 to 95 percent of them suffering from type 2 diabetes, according to Lilly.

Lilly's wide portfolio of diabetes drugs, including Humalog and Trulicity, contributed at least 38 percent to its total sales of $6.36 billion in the last quarter. 

***

Eli Lilly investigational dual GIP and GLP-1 receptor agonist shows significant reduction in HbA1c and body weight in people with type 2 diabetes  

• At 26 weeks, the primary analysis showed a robust dose response compared to placebo throughout the entire dose range of GIP/GLP-1 RA included in the study.
• The analysis of participants while on treatment comparing GIP/GLP-1 RA to dulaglutide and placebo showed significant improvements across endpoints.
• HbA1c reduction: All GIP/GLP-1 RA doses and dulaglutide showed significant blood sugar improvement (mean absolute reduction) from baseline [GIP/GLP-1 RA: -1.6% (5 mg), -2.0% (10 mg), and -2.4% (15 mg); dulaglutide -1.1% (1.5 mg)] compared to placebo (0.1%).
• The safety and efficacy of Lilly's GIP/GLP-1 RA are being studied further in a large phase 3 clinical program that will be referred to as the SURPASS program. Phase 3 studies for type 2 diabetes are expected to begin no later than early 2019 and complete in late 2021. Lilly is evaluating next steps in the study of GIP/GLP-1 RA for obesity and other conditions.

Eli Lilly announces that empagliflozin met the primary efficacy endpoint for all doses investigated (2.5, 10 and 25 mg) in the Empagliflozin as Adjunctive to inSulin thErapy Phase III program in adults with type 1 diabetes 

In EASE-2, placebo-corrected mean change from baseline in A1C at week 26 was -0.54 percent and -0.53 percent for empagliflozin 10 and 25 mg, respectively. In EASE-3, placebo-corrected mean change from baseline in A1C at week 26 was -0.28 percent, -0.45 percent and -0.52 percent for empagliflozin 2.5 mg, 10 mg and 25 mg, respectively. In addition to reduction in A1C, empagliflozin treatment was effective on secondary endpoints, showing reductions in weight, decreases in blood pressure, and decreases in total daily insulin dose. In addition, data from continuous glucose monitoring in the EASE program indicates that patients treated with empagliflozin had improved glycemic variability and spent more time in range, although the data for the 2.5 mg dose are limited.

• Based on the totality of the EASE data, partner Boehringer Ingelheim has initiated regulatory discussions for empagliflozin as adjunct to insulin for adults with type 1 diabetes.

ARMO BioSciences (ARMO) to be acquired by Eli Lilly (LLY) for $50.00/share

 

ARMO BioSciences to be acquired by Eli Lilly (LLY) for $50.00/share, or approximately $1.6 billion, in an all-cash transaction
The acquisition will bolster Lilly's immuno-oncology program through the addition of ARMO's lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Lilly will promptly commence a tender offer to acquire all shares of ARMO BioSciences for a purchase price of $50 per share in cash, or approximately $1.6 billion. The transaction is expected to close by the end of the second quarter of 2018

** charts before **
ARMO

LLY

=Eli Lilly (LLY): global workforce reductions

Eli Lilly announces global workforce reductions that are expected to impact approx. 3,500 positions; co expects annualized savings of approx. $500 million that will begin to be realized in 2018(80.51 )

Co expects the majority of the positions eliminated to come from a U.S. voluntary early retirement program, which is being offered to employees who meet certain criteria.

• Those who participate will receive enhanced retirement benefits.
• The program, announced to U.S. employees on September 7, 2017, will be largely completed by December 31, 2017.
• Remaining positions will come from other anticipated workforce reductions, including select site closures.
• In addition to the U.S. voluntary early retirement program, the company will determine where it needs to further reduce costs and improve efficiencies.
• Lilly expects to incur charges of ~$1.2 billion pre-tax or $0.80 per share after-tax, which includes the estimated participation of the U.S. voluntary early retirement program, global severance and facility closures.
  • The company's reported earnings per share guidance in 2017 will be reduced by the amount of the charges.
  • There will be no change to the company's non-GAAP EPS guidance as a result of these initiatives.
• The annualized workforce savings of ~$500 million will be about equally split to improve the company's cost structure and reinvest in the business, including product launches and clinical development for new indications and line extensions.

=Eli Lilly (LLY) reported earnings on Tue 25 July 2017 (b/o)

• Incyte (INCY) -- Lilly's partner on the arthritis drug

A delay in getting its rheumatoid arthritis drug to market by at least 18 months sent Eli Lilly (LLY) shares lower Tuesday as the drug giant reported second-quarter earnings.

The Food and Drug Administration is requiring Lilly and Incyte to run another trial to determine the benefits and risks across doses of the drug, now known as baricitinib, before resubmitting their application for approval.

Lilly estimates at least 18 months to resubmit the application, putting the approval of baricitinib beyond 2017. Baricitinib is approved in Europe to treat moderate-to-severe rheumatoid arthritis.

Also early Tuesday, Lilly reported $5.82 billion in second-quarter sales, just lagging the consensus for $5.89 billion. Adjusted profits of $1.11 per share topped by 7 cents. Revenue grew 8% with profits per share up 29%.

Diabetes drug Trulicity and plaque psoriasis drug Taltz led growth in the quarter, up 139% and 618%, respectively, vs. the year-earlier quarter. Sales of Basaglar, an insulin to treat adults and children with Type 1 diabetes, grew 432%.

Lilly also raised its 2017 sales guidance to $22 billion to $22.5 billion, up from earlier views for $21.8 billion to $22.3 billion. Adjusted income was raised to $4.10-$4.20 a share for the year, which would be up 16%-19% from 2016.

=Nektar Therapeutics (NKTR) signs a drug-development deal with Eli Lilly (LLY)

Nektar Therapeutics and Lilly (LLY) announce strategic collaboration to co-develop NKTR-358; Nektar will receive an initial payment of $150 mln and is eligible for up to $250 mln in additional development and regulatory milestones:

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

• Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.
• Lilly commentary on impact of transaction:
  • Subject to the closing of this transaction, Lilly expects to incur an acquired in-process research and development charge to earnings in 2017 of approximately $0.09 per share. The company's reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company's non-GAAP earnings per share guidance as a result of this transaction.

=Eli Lilly (LLY) reported earnings on Tue 25 Apr 2017 (b/o)

(Reuters) - Eli Lilly and Co reported a bigger-than-expected quarterly adjusted profit as sales of its newest products, including a diabetes injection, more than doubled.

The Indianapolis-based drugmaker reported strong first-quarter demand for its Trulicity diabetes treatment and its psoriasis drug, Taltz, as well as its Cyramza lung cancer treatment.

"Lilly's new product launches, including Trulicity and Taltz, led the company to a strong quarter of volume-driven revenue growth," David Ricks, who took over as chief executive on Jan. 1, said in a statement.

Lilly took a $150 million charge in November associated with the failed trial of its Alzheimer's drug, solanezumab. This month, the U.S. Food and Drug Administration declined to approve a rheumatoid arthritis drug developed with Incyte Corp.

The company's diabetes treatments, however, continue to sell well.

Trulicity, an injectable treatment that competes with Novo Nordisk's blockbuster Victoza, brought in $372.9 million during the quarter - ahead of the analyst consensus of $328 million, according to Barclays.

Revenue from Lilly's biggest-selling diabetes drug, Humalog, rose 17 percent to $708.4 million, above the consensus estimate of $638 million.

"We are encouraged by another solid performance from Lilly's overall diabetes franchise," Leerink Partners analyst Seamus Fernandez said in a note.

Lilly posted a net loss of $110.8 million, or 10 cents per share, for the first quarter ended March 31, compared with a profit of $440.1 million, or 41 cents per share, a year earlier.

The company recognized a charge of $857.6 million in the latest quarter related to the acquisition of CoLucid Pharmaceuticals, which the drugmaker bought in January for about $960 million.

Excluding items, the company earned 98 cents per share, above the average analyst estimate of 96 cents, according to Thomson Reuters I/B/E/S.

Revenue rose 7.5 percent to $5.23 billion, ahead of the average analyst estimate of $5.22 billion.