UK access to medicines hampered by supply issues and Brexit

Medicine shortages have become more common in the UK in the past few years, according to research by the Nuffield Trust.

Although global problems with supply chains and the availability of key ingredients are the main reason for the shortages, the UK’s exit from the European Union has weakened the country’s ability to tackle the issue by splitting it from European supply chains, authorisations and collective efforts to respond to shortages, the report said.

We now have a “new normal” of frequent disruption to supplies of crucial products including antibiotics and epilepsy drugs.

Compared to three years ago, drugs companies are issuing more than double the number of notifications warning of impending shortages: in 2023 there were 1,634 such alerts issued, compared to 648 in 2020.

“More and more patients across the UK are experiencing a pharmacist telling them that their medication is not available, it may not be available soon, and it may not be available anywhere nearby,” said Mark Dayan, Brexit programme lead at the Nuffield Trust. “This is also creating a great deal of extra work for both GPs and pharmacists.

“We know many of the problems are global and relate to fragile chains of imports from Asia, squeezed by Covid-19 shutdowns, inflation and global instability.

“Officials in the UK have put in place a much more sophisticated system to monitor and respond, and used extra payments to try to keep products flowing. But exiting the EU has left the UK with several additional problems — products no longer flow as smoothly across the borders with the EU, and in the long term our struggles to approve as many medicines might mean we have fewer alternatives available.”

Shire to recommend sweetened Takeda takeover bid

Biotech giant Shire has said it would be willing to recommend an amended $64bn takeover bid from Takeda Pharmaceutical Co to shareholders, according to Reuters.

The rare disease specialist made the statement amid concerns about Takeda’s recent share value losses, with a 7% drop as investors expressed concern over the company’s ability to acquire a company twice its size. If the bid is to go ahead, Shire shareholders will need to accept a bid that is 56% newTakeda shares.

Since news of a possible bid from Takeda broke, shares in the company have fallen 18%, making the deal less attractive to Shire shareholders.

Jefferies analyst David Steinberg said: “While this offer represents a solid improvement over Takeda’s third bid (38% cash), we still wonder if it is enough to satisfy Shire shareholders.”

Shire’s shares rose 1.5% to £39.90 in early London trading, a figure well below Takeda’s £49 offer. Takeda’s fall in share price erodes their $64bn headline offer.

The fifth offer from Takeda is worth £49.01 a share, made up of £27.26 per share in new Takeda shares and £21.75 in cash. This is 4.3% higher than Takeda’s fourth offer on 20 April and 11.4% up on the first approach, made on 29 March.

Irish biotech group Elan puts itself on the block after advising against hostile bid from RP Management

Irish biotechnology firm Elan Corp plc (NYSE:ELN) said it was launching a formal sale given expressions of interest it had received and would invite hostile suitor RP Management LLC (Royalty Pharma) to take part in the process.

Elan also once again advised against acceptance of the US investor’s bid, which is subject to the target’s shareholders rejecting four proposed defensive deals at a meeting set for today.

Royalty Pharma is carrying out the bid, which runs until 24 June, via unit Echo Pharma Acquisition Ltd. In addition to the proposed per-share cash price of USD13.00 (EUR9.75), Elan’s shareholders are offered also one contingent value right worth up to USD2.50 a share, which gives the bid a potential total value of USD8bn, according to Reuters. The US firm has said it would use available resources and debt to finance the transaction.

Royalty Pharma said last Friday, it estimates, based on votes already cast, that only one of the four resolutions – a stock buyback programme – had majority backing, which, however, was slim and could be overturned following the ordinary stockholders’ vote.

The suitor was granted last Thursday court injunction in Ireland, allowing it to appeal the country’s takeover watchdog’s denial of its request not to be required to withdraw its hostile bid if any of the ELND005 transaction or the stock buyback programme subject to the shareholder vote is approved. The court is to meet again Wednesday. If the Irish Takeover Panel’s ruling remains in force, the suitor will have to lapse its offer if any of the four defensive deals wins Elan’s shareholders’ backing.

Elan is being advised by Citigroup Inc (NYSE:C), Davy Corporate Finance Ltd, Morgan Stanley (NYSE:MS), Ondra Partners, A&L Goodbody and Cadwalader Wickersham and Taft LLP.

Pharmaceuticals firm Novartis denies talk on bid for generic drug maker Actavis

Swiss pharma major Novartis AG (VTX:NOVN) does not intend to pursue a takeover of US drugmaker Actavis Inc (NYSE:ACT), a company spokesperson told Reuters, refuting a previous report by the Wall Street Journal.

Earlier this week, the paper cited insiders as saying that Novartis was mulling over the possibility of making a bid for Actavis, which had reportedly turned down separate offers from peers Valeant Pharmaceuticals International Inc (TSE:VRX) and Mylan Inc (NASDAQ:MYL).

The WSJ also said that both Valeant and Mylan were considering their options following the rejections.

According to another WSJ source, Valeant was close to a deal for the purchase of Actavis three weeks ago, but had failed to sign one as the latter’s directors recognised just a small premium in the proposed all-stock transaction. In turn, Bloomberg reported that Actavis had turned down a cash-and-stock bid by Mylan, which valued the target at USD120.00 (EUR93.33) per share, or USD15bn in total.

Last week, Actavis announced it was holding early-stage talks in connection with a potential combination with Irish sector player Warner Chilcott plc (NASDAQ:WCRX).

Pharmaceuticals giant GSK increase stake in Indian healthcare unit to 73%

UK drug maker GlaxoSmithKline Plc (LON:GSK) said today it had increased its stake in its Indian unit GlaxoSmithKline Consumer Healthcare Ltd to 72.5% from 43.2%, as part of a voluntary tender offer launched by its subsidiary GlaxoSmithKline Pte Ltd.

During the offer period, which ran from 17 January to 30 January, some 12.3m shares of the target, or 29.3% of its total stock, were validly tendered. The buyer has proposed INR3,900 (USD73.23/EUR54.15) apiece, giving the deal a value of INR48bn (USD901.2m/EUR666.7m).

HSBC Securities and Capital Markets (India) Private Limited is managing the offer, which was originally unveiled on 26 November 2012. The final payment date is on or before 13 February, GSK said.

The transaction will allow GSK to further bolster its presence in India, which it considers a key emerging market, it added.

British drugs giant GSK could announce a deal for HGS today

British drugmaker GlaxoSmithKline Plc (LON:GSK) is seen to increase to some USD14.00 (EUR11.43) a share, or around USD2.8bn in total, from USD13.00 per share, its bid to buy US biopharmaceutical firm Human Genome Sciences (NASDAQ:HGSI), or HGS, and could announce an agreement on Monday, according to Reuters sources.

The parties are currently negotiating the final details of a transaction, the informed people told the news agency.

The move comes as Human Genome investors have been pressing for talks with hostile bidder GSK after no alternative offers came in during an auction process carried out as part of the company’s strategic review, the report said.

The British group took its offer to HGS shareholders in May after the target’s board turned it down earlier in April. It set 20 July as the deadline for its bid allowing it to run beyond the 16 July deadline set by HGS for final offers to be submitted as part of its strategic review. GSK, which declined to participate in that process, said the extension to its bid would enable HGS shareholders to compare the results of the board’s review to the hostile offer.

The transaction offers immediate premium liquidity to HSG’ investors, while sparing them the inevitable high risk involved in HSG pursuing its future growth objectives, the buyer explained.
It is also in line with GSK’s long-term growth strategy and would help it simplify its business model.

GSK has repeatedly said it was willing to meet with HGS and review its takeover proposal at any time, but the talks during the weekend have been initiated by Human Genome, according to one of the sources cited by Reuters.

For more on this story, click here.

Genova Diagnostics buys Metametrix

US diagnostic testing specialist Genova Diagnostics Inc said it had acquired clinical laboratory tests provider Metametrix Inc for an undisclosed sum.

Following the transaction, Metametrix’s chief executive officer Dr Alexander Bralley will become a consultant to the new organisation, concentrating on testing approaches and clinical education programmes development. At this point the combined group will continue to operate under the two brands.

Genova Diagnostics’ chief executive and chairman Ted Hull said that through the deal the company will be able to expand its geographic footprint. Hull further said that the parties plan to increase investments in R&D, clinical studies, medical education and market expansion.

The combined entity will serve more than 9,000 healthcare practitioners per year across the US and 45 territories. It will have a headcount of 400 based in three locations in Asheville, North Carolina, Duluth, Georgia, and London, the UK.

Metametrix, formed in 1984, develops technology for the measurement of nutritional insufficiencies, metabolic dysfunction, microbial imbalances and toxic influences on health. Genova was created in 1986 and is focused on clinical laboratory testing for the diagnosis, treatment and prevention of complex chronic disease.

Human Genome recommends stockholders reject GSK’s bid

US biopharmaceutical firm Human Genome Sciences (NASDAQ:HGSI), or HGS, reiterated its advice to shareholders not to tender their stock to the $13.00 (EUR10.30) a share hostile takeover offer from GlaxoSmithKline Plc (LON:GSK), after the British suitor announced an extension to 20 July of its $2.6bn worth bid.

HGS’ board said that less than 1% of the company shares had been tendered to GSK’s offer which was taken to HGS shareholders in May, after the target’s board turned it down as inadequate and not reflecting the firm’s inherent value.

GSK, whose bid was to expire on 29 June, said on Friday it had decided to extend it beyond the 16 July deadline set by HGS for final offers to be submitted as part of its strategic review, in a move to allow HGS shareholders the opportunity to compare the results of the board’s review to the hostile offer.

Reacting to that, HGS said it planned to complete its strategic review as rapidly as possible in a way that would give shareholders the chance to benefit from a complete and fair process.

The US company has invited GSK twice to take part in the review, but the British drugmaker declined both invitations, saying that its offer was not subject to due diligence or financing.

GSK is still willing to meet with HGS and review its takeover proposal at any time, it added.
The transaction offers immediate premium liquidity to HSG’ investors, while sparing them the inevitable high risk involved in HSG pursuing its future growth objectives, the buyer has explained.

It is also in line with GSK’s long-term growth strategy and would help it simplify its business model.

Goldman, Sachs & Co, Credit Suisse Securities (USA) LLC, Skadden, Arps, Slate, Meagher & Flom LLP and DLA Piper LLP (US) are serving as advisors to HGS.

Bristol-Myers Squibb agrees $5.3bn deal to acquire Amylin

US pharmaceutical group Bristol-Myers Squibb Co (NYSE:BMY) said it had made an agreement to buy diabetes-focused biopharmaceutical firm Amylin Pharmaceuticals Inc (NASDAQ:AMLN) at U$31.00 (€24.50) in cash per share, or $5.3bn in total, plus assumption of around $1.7bn of debt.

With this move, Bristol-Myers Squibb will add innovative diabetes products, talent and state-of-the art manufacturing facility to its portfolio, in a move to boost its top position in metabolics, CEO Lamberto Andreotti said. The deal also allows Bristol-Myers Squibb to widen its alliance with British biopharmaceutical company AstraZeneca Plc (LON:AZN) through an accord regarding the development and commercialisation of Amylin’s portfolio of products.

The collaboration arrangement with AstraZeneca, backed by the boards of both parties, calls for the British group to pay some $3.4bn in cash to Amylin as a fully-owned unit of Bristol-Myers Squibb, with profits and losses to be equally shared.

This payment will be made following the completion of Bristol-Myers Squibb’s acquisition of Amylin.

Amylin’s board approved the takeover by Bristol-Myers Squibb and advised shareholders to tender their stock to the 30-day offer, which is subject to securing at least a majority of the target’s shares as well as the Hart-Scott-Rodino (HSR) clearance. The tender bid will be followed by a short-term merger.

Bristol-Myers Squibb said it would use existing cash and debt to finance the purchase.

In a comment, Amylin’s CEO and president Daniel M. Bradbury said that the deal with Bristol-Myers Squibb and their alliance with AstraZeneca provide an opportunity to maximise the potential and impact of the firm’s diabetes therapies whose global reach will be extended. The agreement follows a several months long strategic review of options by Amylin focused on finding a way to maximise the value of its diabetes franchise, the CEO added.

For its part, AstraZeneca expects the collaboration agreement to immediately contribute to its revenues, as part of a strategy to step up growth and enhance late stage pipeline, interim CEO Simon Lowth said.

Citigroup Inc (NYSE:C), Evercore Partners Inc (NYSE:EVR) and Kirkland & Ellis LLP are advising Bristol-Myers Squibb, while Amylin has engaged the services of Credit Suisse Securities (USA) LLC, Goldman Sachs & Co and Skadden, Arps, Slate, Meagher & Flom LLP.

AstraZeneca’s advisors are Bank of America Merrill Lynch, Davis Polk & Wardwell LLP and Covington & Burling LLP.

US biopharma group Spectrum extends its offer for Allos Therapeutics

US biopharmaceutical firm Spectrum Pharmaceuticals Inc (NASDAQ:SPPI) has once again prolonged its tender bid to take over anti-cancer therapeutics specialist Allos Therapeutics Inc (NASDAQ:ALTH), this time until 22 June 2012, the pair announced.

The extension is needed as the two companies continue to work with the Federal Trade Commission (FTC) to obtain clearance under the Hart-Scott-Rodino act. On 9 May, the FTC made a request for additional information regarding the deal in order to make its ruling. Spectrum has already prolonged its tender offer twice since that date.

The agreement on the transaction was first announced on 5 April 2012 and the tender bid commenced on 13 April. The offer includes a cash payment of USD1.82 (EUR1.46) per share plus one contingent value right (CVR) for additional USD0.11 a share based on the achievement of some regulatory and commercialisation milestones.

The upfront portion of the price is valued at up to USD206m in total and USD108m net of Allos’ cash balance at the end of 2011, Spectrum has said. It plans to cover the price with existing cash and debt.

The buyer had previously said that the acquisition would provide a new diversified revenue source.

Allos is the developer of the Folotyn drug for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), approved by the US Food and Drug Administration (FDA) in September 2009.