Avenue Therapeutics announced that the first patient has been dosed in a pivotal Phase 3 clinical trial of IV tramadol for the management of moderate to moderately severe pain in patients following abdominoplasty surgery. The Phase 3, multicenter, randomized, double-blind, three-arm trial will evaluate the efficacy and safety of IV tramadol 50 mg versus placebo. Approximately 360 patients will be enrolled to IV tramadol 50 mg, placebo or morphine in a 3:3:2 ratio. The primary efficacy endpoint is the summed pain intensity difference over 24 hours compared to placebo.
Wednesday, December 19, 2018
Allergan suspends sales of textured breast implants in European markets
Allergan announced that the company has suspended sales of textured breast implants and tissue expanders and is withdrawing any remaining supply in European markets. The withdrawal decision follows a compulsory recall request from Agence Nationale de Securite du Medicament, the French regulatory authority. The suspension of sales stems from the expiration of the company’s CE Mark for these products. Although Allergan disagrees with ANSM’s request, the Company is fully cooperating with the authority. Allergan stands behind the benefit/risk profile of our breast implant products. The ANSM request, and this action, is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants. The Company looks forward to participating in the scientific forum that ANSM has scheduled for early February where the full set of data and scientific evidence for textured breast implants can be presented and thoroughly discussed by all stakeholders. Allergan will continue to work through the CE Mark renewal with GMED, and is planning an appeal to ensure that appropriate patients have access to the products that their surgeons recommend. Importantly, the CE Mark for Allergan’s smooth implants has been renewed by GMED. Smooth implants are not affected and continue to be available for patients. It is also important to note that the United States does not require the CE Mark so it is unaffected by the action.
‘GSK to split after striking Pfizer consumer health deal’: Reuters
GlaxoSmithKline plans to split into two businesses — one for prescription drugs and vaccines, the other for over-the-counter products — after forming a new joint venture with Pfizer’s consumer health division.
The revamp is the boldest move yet by GSK Chief Executive Emma Walmsley, who took over last year.
It will lead to the creation of a consumer health giant with a market share of 7.3 percent, well ahead of its nearest rivals Johnson & Johnson, Bayer and Sanofi, all on around 4 percent.
Walmsley has previously played down the idea of breaking up the group, something that a number of investors have called for over the years.
On Wednesday, however, she announced that GSK and Pfizer would combine their consumer health businesses in a joint venture with sales of 9.8 billion pounds ($12.7 billion), 68 percent-owned by the British company, in an all-equity transaction.
GSK said the deal laid the foundation for the creation of two new UK-based global companies focused on pharma/vaccines and consumer healthcare within three years of the transaction closing.
For Pfizer, the deal resolves the issue of what to do with its consumer health division, which includes Advil painkillers and Centrum vitamins, after an abortive attempt to sell it outright earlier this year.
GSK, whose consumer products include Sensodyne toothpaste and Panadol painkillers, had withdrawn from that earlier Pfizer auction process but Walmsley said the opportunity to strike an all-equity deal cleared the way for the new agreement.
“It’s something we’ve been able to do quickly and quietly,” she told reporters in a conference call.
“What this deal is all about is the opportunity to strengthen two businesses — a world-leading consumer healthcare business and a new GSK that is focused on pharma and vaccines.”
CRYSTALLIZING VALUE
Shareholders welcomed the news and the shares jumped 7 percent, with Jefferies analysts saying the future separation could crystallize value.
The new joint venture with Pfizer is expected to generate total annual cost savings of 500 million pounds by 2022 for expected total cash costs of 900 million and non-cash charges of 300 million. GSK plans divestments of some 1 billion pounds.
Walmsley said there would be an inevitable impact on jobs but there was also an opportunity for cost savings in procurement and across the supply chain.
The Pfizer deal is expected to boost adjusted earnings and free cashflow in the first full year after closing, which GSK anticipates will occur in the second half of 2019.
Pfizer, which already has a long-standing HIV medicines joint venture with GSK, said the transaction would be slightly accretive in each of the first three years after it closed.
The consumer tie-up follows a deal by GSK earlier this year to buy Novartis’s stake in their consumer joint venture for $13 billion and comes as Walmsley tries to reshape Britain’s biggest drugmaker, which has seen its shares move sideways for years.
Earlier this month, she agreed to buy cancer drug specialist Tesaro for $5.1 billion to try to revitalize its pharmaceuticals business, a high-priced acquisition that was poorly received by the market.
GSK has lagged rivals in recent years in producing multibillion-dollar blockbusters and it largely sat out a spate of dealmaking by rivals under previous CEO Andrew Witty.
Seeking to reassure investors of its financial strength, GSK extended its guarantee on the dividend by stating it expected to pay unchanged dividends of 80 pence per share for 2019.
GSK was advised by Citi, J.P. Morgan Cazenove and Greenhill, while Centerview, Guggenheim and Morgan Stanley acted for Pfizer.
Cellectis initiated at Goldman Sachs
Cellectis initiated with a Neutral at Goldman Sachs. Goldman Sachs analyst Salveen Richter started Cellectis with a Neutral rating and $25 price target. The analyst says it is time for the company to execute on its gene editing platform technology and prefers to remain on the sidelines pending clinical data readouts in 2019.
https://thefly.com/landingPageNews.php?id=2838981
Sandoz enters into commercialization, supply agreement for insulin biosimilars
Sandoz, a Novartis division, announced that it has entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. These medicines are currently in early and clinical stages of development for the European Union, United States and other key territories. The commercialization and supply agreement with Gan & Lee aims at bringing to market biosimilar versions of glargine, lispro and aspart, the three top insulin medicines by sales. Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years’ experience in insulins and production capacity with attractive cost of goods sold structures. Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, U.S., Switzerland, Japan, South Korea, Canada, Australia and New Zealand. Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential.
https://thefly.com/landingPageNews.php?id=2838991
Pfizer, GSK to merge consumer healthcare units into joint venture
Pfizer (PFE) and GlaxoSmithKline (GSK) announced they have entered into an agreement to create a consumer healthcare company. The boards of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7B. Under the terms of the transaction, Pfizer will receive a 32% equity stake in the joint venture, entitling Pfizer to its pro rata share of the joint venture’s earnings and dividends, which will be paid on a quarterly basis. Pfizer will have the right to appoint three out of the nine members of the joint venture’s board. The transaction is expected to deliver $650M in peak cost synergies and to be slightly accretive for Pfizer in each of the first three years after the close of the transaction, which is anticipated during the second half of 2019, subject to receipt of GSK shareholder approval and regulatory approvals, and satisfaction of other customary closing conditions. Pfizer anticipates deconsolidating Pfizer Consumer Healthcare from its financial statements following the closing of the transaction. In the near- to medium-term, this deconsolidation is not expected to have a material impact on Pfizer’s top-line growth. In addition, given the Consumer Healthcare business records lower margins than Pfizer’s other businesses, the deconsolidation is expected to have a slight positive impact on Pfizer’s operating margins over the next several years. Following the integration of the combined business, GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the Consumer Healthcare business on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years from closing of the proposed transaction. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO. Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing of the proposed transaction, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture. The joint venture will operate globally under the GSK Consumer Healthcare name. Emma Walmsley, GSK CEO, will be Chair of the new joint venture. Brian McNamara, currently CEO GSK Consumer Healthcare, will be CEO of the new joint venture and Tobias Hestler, currently CFO GSK Consumer Healthcare, will be CFO. GSK has agreed to pay a break fee of $900M if the GSK board changes, withdraws or qualifies its recommendation of the transaction to its shareholders for approval or if its shareholders do not approve the transaction.
https://thefly.com/landingPageNews.php?id=2838993
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